Drug recalls
Enforcement reports from the FDA's weekly recall database. Recalls are classified by the health hazard the defect presents: Class I where exposure is reasonably likely to cause serious harm or death, Class II where it may cause temporary or reversible harm, and Class III where it is unlikely to cause harm.
17,975 records · source: openFDA Enforcement
All classes 17,975 Class II 14,511 Class I 1,747 Class III 1,715 Not Yet Classified 2
| Class | Reported | Product | Reason | Firm | Status |
|---|---|---|---|---|---|
| Class II | September 23, 2015 | MEGA-BURN* Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Morphine 40 mg/ml + Bupivacaine 8 mg/ml Solution, Sterile-Preservative Free, The… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Morphine 40 mg/ml + Fentanyl 2,000 mcg/ml Solution, Sterile-Preservative Free, The… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Testosterone Cypionate 150 mg/ml Injection Multi-Dose Vial, Sterile, Room Temperature,… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | HCG 1,000 IU/ml + Methylcobalamin 1 mg/ml Injection, Multi-Dose Vial, Sterile,… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | HCG 5,000 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding Pharmacy… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Testosterone Bi-Blend 15 mg/ml +Estradiol Valerate 5 mg/ml Injection, Multi-Dose… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Mitomycin 0.02% Ophthalmic Solution, single dose dropper, Keep Frozen, The Compounding… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Hydromorphone 20 mg/ml + Bupivacaine 0.25 mg/ml Solution, Sterile-Preservative Free, The… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | MEGA-BURN Injectable ROCK CREEK, Multi-Dose Vial, Sterile, Room Temperature, The… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Testosterone 100 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Calmme Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Sufentanil 50 mcg/ml + Bupivacaine 0.25 mg/ml Solution, Sterile-Preservative Free, The… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | HCG 1,200 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding Pharmacy… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Sodium Ascorbate 500 mg/ml Injection, Preservative Free Vial, Sterile, Refrigerate, The… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Testosterone USP Aqueous 200 mg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature,… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Tri-Mix T-102 (17.65 mg/0.59 mg/10 mcg) Injectable, The Compounding Pharmacy of America,… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class III | September 23, 2015 | Dexmethylphenidate HCl Extended-Release, Capsules, 10mg, Rx only, 100 Capsules.… | Failed Dissolution Specifications: Product is being recalled due to out of specification (above specification) result… | Novartis Pharmaceuticals Corp. | Terminated |
| Class II | September 23, 2015 | Mitomycin 40 mg/40 ml Sodium Chloride 0.9% Injection, Single Dose Syringe, Refrigerate,… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Fentanyl 1,000 mcg/ml Intrathecal Solution, Sterile-Preservative Free,The Compounding… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Folic Acid 5 mg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, The Compounding… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Morphine 30 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Testosterone 75 mg Pellet, Sterile, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Fentanyl 5,000 mcg/ml Intrathecal Solution, Sterile - Preservative Free, The Compounding… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Estradiol 25 mg, Sterile Pellet, The Compounding Pharmacy of America, Inc., Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Testosterone 62.5 mg Pellet, Sterile, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Alprostadil 40 mcg/ml Injection, Sterile, Keep Frozen, The Compounding Pharmacy of… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Vancomycin 25 mg/ml Ophthalmic Solution, Single Dose, Sterile, Keep Frozen, The… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Tri-Mix (20/2.5/20) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Tri-Mix (17.7 mg/1 mg/10 mcg) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Testosterone 70 mg Pellet, Sterile, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Testosterone 200 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Testosterone USP (10 AQUEOUS) 100 mg/ml Injection, Multi-Dose Vial, Sterile, Room… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Mannitol 5% Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Testosterone 70 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Fentanyl 500 mcg/ml Intrathecal Solution, Sterile - Preservative Free, The Compounding… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Fentanyl 100 mcg/ml +Clonidine 400 mcg/ml Intrathecal Solution, Sterile-Preservative… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Alprostadil 50 mcg/ml Injection, Sterile, Keep Frozen, The Compounding Pharmacy of… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | HCG 5,000 IU/ml + Methylcobalamin 500 mcg/ml Injection, Multi-Dose Vial, Sterile,… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Hydromorphone 10 mg/ml + Bupivacaine 10 mg/ml Solution, Sterile-Preservative Free, The… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Morphine 10 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Tri-Mix (30/1/10) Injectable, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Collagenase 250 units/ml, Sterile, Multi-Dose Vial, Refrigerate, The Compounding Pharmacy… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Testosterone 200 mg Anastrazole 9 mg Pellet, Sterile, The Compounding Pharmacy of… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Hydromorphone 60 mg/ml + Fentanyl 15,000 mcg/ml + Bupivacaine 35 mg/ml + Clonidine 1,200… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Polidocanol 5% Injection, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Hydroxocobalamin 5,000 mcg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, The… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Hydromorphone 40 mg/ml + Bupivacaine 40 mg/ml Solution, Sterile-Preservative Free, The… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Morphine 64 mg/ml + Bupivacaine 10 mg/ml Solution, Sterile-Preservative Free, The… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Tri-Mix ST1 (30 mg/1.5 mg/50 mcg) Injectable, The Compounding Pharmacy of America,… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Testosterone Cypionate 40 mg/ml Injectable, 5 Sesame, The Compounding Pharmacy of… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | HCG 1,000 IU/ml + Methylcobalamin 0.05 mg/ml Injection, Multi-Dose Vial, Sterile,… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Tri-Mix T-50/PGE 2/LIDO 2 0.09/0.32/0.04 Injectable, The Compounding Pharmacy of America,… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class III | September 23, 2015 | ClomiPHENE CITRATE Tablets, USP, 50 mg, 10-count (2 foil sealed plastic trays of 5… | Chemical Contamination: impurity failure due to chemical contamination of the active ingredient. | EMD Serono, Inc. | Terminated |
| Class II | September 23, 2015 | Estradiol Cypionate 5mg/ml Injectable, ml Multi-Dose Vial, Sterile Room Temperature, The… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Tri-Mix (18/0.6/5.88) (MFG) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Morphine 40 mg/ml + Clonidine 500 mcg/ml Solution, Sterile-Preservative Free, The… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Hydromorphone 80 mg/ml + Clonidine 1,800 mcg/ml + Baclofen 730 mcg/ml Intrathecal… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Copper (Cupric)Sulfate 2 mg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Tri-Mix (30/2/20) (MFG) Injectable, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Estradiol 6 mg, Sterile Pellet, The Compounding Pharmacy of America, Inc., Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Tri-Mix (30/1/10) (MFG) Injectable, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Sermorelin 1000mcg/GHRP6 1000/GHRP2 1000 ml Injection, Multi-Dose Vial, Sterile,… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Hydromorphone 60 mg/ml + Fentanyl 7,500 mcg/ml + Bupivacaine 30 mg/ml + Clonidine 1,100… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Morphine 35 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Testosterone 30 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | HCG 5,000 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding Pharmacy… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Morphine 50 mg/ml + Fentanyl 20,000 mcg/ml + Bupivacaine 30 mg/ml + Clonidine 1,200… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Fentanyl 20,000 mcg/ml + Bupivacaine 30 mg/ml + Clonidine 1,300 mcg/ml + Baclofen 350… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Estradiol 10 mg Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Morphine 20 mg/ml + Clonidine 500 mcg/ml Solution, Sterile-Preservative Free, The… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | LIPOLEAN + Ascorbic Acid 50 mg/ml Injectable, Multi-Dose Vial, Sterile, Room Temperature,… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Morphine 36 mg/ml + Bupivacaine 40 mg/ml Solution, Sterile- Preservative Free, The… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Glutathione 200 mg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, The Compounding… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Quad-Mix 2 Injectable, Multi-Dose Vial, Sterile, Keep Frozen, The Compounding Pharmacy of… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Hydromorphone 60 mg/ml + Bupivacaine 30 mg/ml Solution, Sterile-Preservative Free, The… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | HCG 10,000 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Hydromorphone 35 mg/ml + Bupivacaine 10 mg/ml + Baclofen 1,500 mcg/ml + Clonidine 200… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Acetyl-L-Carnitine 500 mg/ml, Injectable, Sterile-Multi-Dose Vial, The Compounding… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Methylcobalamin 1,000 mcg/ml + Hydroxocobalamin 1,000 mcg/ml Injectable, Preservative… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Testosterone 80 mg Pellet, Sterile, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Mitomycin 0.03% Ophthalmic Solution, ml single dose dropper, Keep Frozen, The Compounding… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Neomycin + Polymyxin B+ Bacitracin Ophthalmic Ointment, grams, Refrigerate, The… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Morphine 20 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Magnesium Sulfate 500 mg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | MIC+Methylcobalamin 4000 mcg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature,… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Fentanyl 10,000 mcg/ml + Bupivacaine 40 mg/ml Intrathecal Solution, Sterile-Preservative… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Methionine 25 mg/ml + Inositol 50 mg/ml + Choline 50 mg/ml Injectable, Multi-Dose Vial,… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Cholecalciferol 500,000 IU/ml Injectable, ml Vial, Sterile, Refrigerate, The Compounding… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Tri-Mix (17.7 mg/0.59 mg/6 mcg) Injectable, Sterile, Keep Frozen, The Compounding… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Testosterone 60 mg Anastrazole 4 mg Pellet, Sterile, The Compounding Pharmacy of America,… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Morphine 12.5 mg/ml Solution, Sterile-Preservative Free,The Compounding Pharmacy of… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | HCG 1,000 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, 15 DAY KIT, The… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Morphine 25 mg/ml + Bupivacaine 30 mg/ml + Clonidine 200 mcg/ml Solution, Sterile,… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Tri-Mix (30/1/20) (MFG) Injectable, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | HCG 1,250 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding Pharmacy… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Alprostadil 10 mcg/ml Injection, Sterile, Keep Frozen, The Compounding Pharmacy of… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Fentanyl 1,000 mcg/ml + Bupivacaine 25 mg/ml Baclofen 500 mcg/ml + Clonidine 500 mcg/ml… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Hydromorphone 70 mg/ml + Bupivacaine 20 mg/ml + Clonidine 125 mcg/ml Intrathecal… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Estradiol 12.5 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Testosterone Cypionate 100 mg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature,… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Hydromorphone 70 mg/ml+Fentanyl 16,000 mcg/ml+Bupivacaine 15 mg/ml+Clonidine 1,000… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Hyaluronidase 150 units/ml Injection, ml, Sterile, Preservative Free, Refrigerate, The… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Tri-Mix T-105 (30 mg/1 mg/10 mcg) Injectable, The Compounding Pharmacy of America,… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | MYO-DEN (30 ml) 25 mg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature, The… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Sufentanil 50 mcg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | HCG 1,000 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, 23 DAY KIT, The… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | B-Complex 100 mg/ml Injection, Sterile, Refrigerate, The Compounding Pharmacy of America,… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Testosterone 12.5 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Hydromorphone 35 mg/ml + Bupivacaine 4 mg/ml Intrathecal Solution, Sterile-Preservative… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Hydromorphone 70 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Morphine 50 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Betamethasone Sodium Phosphate (10 ml) 30 mg/ml Injectable, The Compounding Pharmacy of… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Cyanocobalamin 10 mg Pellet, Sterile, Room Temperature, The Compounding Pharmacy of… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Hydromorphone 45 mg/ml + Fentanyl 10,000 mcg/ml + Bupivacaine 15 mg/ml + Baclofen 720… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Morphine 25 mg/ml + Baclofen 100 mcg/ml Solution, Sterile-Preservative Free, The… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Hydromophone 10 mg/ml + Clonidine 300 mcg/ml + Baclofen 120 mcg/ml Intrathecal Solution,… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Hydromorphone 5 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Testosterone Propionate 100 mg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature,… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | MYO-DEN Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Brompheniramine Maleate 20 mg/ml Injectable, Vial, Sterile, Room Temperature, The… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Tri-Mix (30/1/22) Injectable, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Morphine 30 mg/ml + Baclofen 10 mcg/ml Solution, Sterile-Preservative Free, The… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Testosterone Enanthate 200 mg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature,… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | HCG 1,000 IU/ml + Methylcobalamin 0.5 mg/ml Injection, Multi-Dose Vial, Sterile,… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Tri-Mix T-50/PGE 1 0.14/0.08 Injectable, The Compounding Pharmacy of America, Knoxville,… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Morphine 45 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | HCG 11,000 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Tri-Mix (30/1/20) Injectable, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | PGE 150 (Alprostadil) 150 mcg/ml, ml, Multi-Dose Vial, Sterile, Keep Frozen, The… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | MIC-B COMPLEX Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | HCG 625 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, 23 DAY KIT, The… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Nandrolone Decanoate 250 mg/ml Injection, ml Multi-Dose Vial, Sterile, Room Temperature,… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Alprostadil 20 mcg/ml Injection, Sterile, Keep Frozen, The Compounding Pharmacy of… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | MEGA-BURN, Winning at Weight Loss Formula Injectable, Multi-Dose Vial, Sterile, Room… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Lipotropic B-12 Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | PGE 80 (Alprostadil) 80 mcg/ml Injection, Multi-Dose Vial, Sterile, Keep Frozen, The… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Fentanyl 2,000 mcg/ml + Bupivacaine 30 mg/ml Intrathecal Solution, Sterile - Preservative… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Biotin10 mg/ml Injectable, ml Multi-Dose Vial, Sterile, Refrigerate, the Compounding… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Hydroxocobalamin 10 mg/ml Folic Acid 4 mg/ml Injectable, ml Multi-Dose Vial, Sterile,… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Buckshot Injectable, Multi-Dose, Sterile, Room Temperature, The Compounding Pharmacy of… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Cholecalciferol 600,000 IU/ml Injectable, ml Vial, Sterile, Refrigerate, The Compounding… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Morphine 50 mg/ml + Fentanyl 3,000 mcg/ml + Baclofen 450 mcg/ml, Sterile, Preservative… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Tri-Mix MEDIUM (15 mg/0.5 mg/5 mcg) Injectable, The Compounding Pharmacy of America,… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Tri-Mix Super Injectable, Multi-Dose Vial, Sterile, Keep Frozen, The Compounding Pharmacy… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Acetylcysteine 100 mg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Hydromorphone 20 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Morphine 25 mg/ml + Bupivacaine 20 mg/ml + Clonidine 2,000 mcg/ml Solution, Sterile,… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Hyaluronic Acid Sodium 28 mg/ml + Lidocaine HCl 3 mg/ml Injection, ml Syringe, Sterile,… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Testosterone 20 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | MIC-PLUS Carnitine Injectable, Multi-Dose Vial, Sterile, Room Temperature, The… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | HCG 1,500 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding Pharmacy… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | HCG 1,000 IU/ml + MIC B-12 Injection, Multi-Dose Vial, Sterile, Refrigerate, The… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Tri-Mix ST2 (30 mg/3 mg/100 mcg) Injectable, The Compounding Pharmacy of America,… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Bupivacaine 15 mg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Morphine 50 mg/ml + Clonidine 750 mcg/ml + Baclofen 15 mcg/ml Solution, Sterile,… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Testosterone Cypionate 200 mg/ml Anastrazole 0.25 mg/ml Injection, Multi-Dose Vial,… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Hyaluronidase 175 units/ml Injection, ml, Sterile, Preserved, Refrigerate, The… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Testosterone 200 mg Anastrazole 1 mg Pellet, Sterile, The Compounding Pharmacy of… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | HCG 500 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding Pharmacy… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Testosterone Tri-Blend 200 mg/ml (10 ml Sesame Oil) Injection, The Compounding Pharmacy… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Hyaluronic Acid Sodium 32 mg/ml + Lidocaine HCl 3 mg/ml Injection, ml Syringe, Sterile,… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Methylcobalamin 25,000 mcg/ml Intramuscular, Multi-Dose Vial, Sterile, Refrigerate, The… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | 5-Methyl Tetrahydrofolate (5-MTHF) 1 mg/ml Injectable, Sterile-Multi-Dose Vial, The… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Tri-Mix ST9E (60 mg/4 mg/150 mcg) Injectable, Sterile Keep Frozen, The Compounding… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Testosterone Cypionate 200 mg/ml Anastrazole 2 mg/ml Injection, Multi-Dose Vial, Sterile,… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Testosterone 72.5 mg Pellet, Sterile, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Fentanyl 8,000 mcg/ml + Bupivacaine 30 mg/ml Intrathecal Solution, Sterile-Preservative… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Tri-Mix ST9A (30 MG/2 MG/80 MCG) Injectable, The Compounding Pharmacy of America,… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Testosterone 75 mg and B12 6 mg Pellet, Sterile, The Compounding Pharmacy of America,… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Tri-Mix ST4 (3 mg/1.5 mg/300 mcg) Injectable, The Compounding Pharmacy of America,… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Morphine 40 mg/ml + Bupivacaine 16 mg/ml Solution, Sterile-Preservative Free, The… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Zinc Chloride 25mg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The Compounding… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Methylcobalamin 10 mg/ml + 5 Methyl Tetrahydrofolate 4 mg/ml Injectable,… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Hydromorphone 12.5 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | LIPO-DEN MODIFIED Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Hydroxyprogesterone Caproate (17-HP) 250 mg/ml Injectable, Multi-Dose Vial, Room… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | HCG 2,500 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding Pharmacy… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Fentanyl 5,000 mcg/ml + Bupivacaine 40 mg/ml Intrathecal Solution, Sterile - Preservative… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Fentanyl 8,000 mcg/ml, + Bupivacaine 40 mg/ml Intrathecal Solution, Sterile -… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Sermorelin/GHRP2 1000/1000 mcg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, DO… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Sermorelin 300 mcg/ml + GHRP-2 300 mcg/ml Injection, Multi-Dose Vial, Sterile,… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Sermorelin/GHRP6 1000/1000 mcg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, DO… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Testosterone Bi-Blend 50 mg/ml + Estradiol Valerate 2.5 mg/ml Injectable, The Compounding… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Tri-Mix (25/2.5/10) (MFG) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Hydroxocobalamin 1,000 mcg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, The… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Tri-Mix (37.5 mg/1.5 mg/50 mcg) Injectable, The Compounding Pharmacy of America,… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Hydromorphone 80 mg/ml + Bupivacaine 10 mg/ml + Clonidine 1,000 mcg/ml, Baclofen 500… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Fentanyl 4,000 mcg/ml + Bupivacaine 40 mg/ml Intrathecal Solution, Sterile-Preservative… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Fentanyl 5,000 mcg/ml, + Bupivacaine 15 mg/ml Intrathecal Solution, Sterile -… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | HCG 1,000 IU/ml + Hydroxocobalamin 1,000 mcg/ml Injection, Multi-Dose Vial, Sterile,… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Lipotropic Methyl B-12 Injection, Multi-Dose Vial, Sterile, Room Temperature, The… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Sufentanil 45 mcg/ml + Bupivacaine 5 mg/ml Solution, Sterile=Preservative Free, The… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Tri-Mix T-106 (30 mg/1 mg/25 mcg) Injectable,The Compounding Pharmacy of America,… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Morphine 50 mg/ml + Clonidine 500 mcg/ml +Bupivacaine 2.5 mg/ml Solution, Sterile,… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Tri-Mix T-102/PGE 2/LIDO 2 0.06/0.3/0.2 Injectable, The Compounding Pharmacy of America,… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Tri-Mix (30/0.5/10) (MFG) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Hydromorphone 3 mg/ml + Baclofen 2,500 mcg/ml Intrathecal Solution, Sterile-Preservative… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Tri-Mix (30/2/20) Injectable, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | HCG 625 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, 42 DAY KIT, The… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Testosterone Cypionate 200mg/ml Injection Multi-Dose Vial, Sterile, Room Temperature, The… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Tri-Mix T-101 (17.65 mg/0.59 mg/5.9 mcg) Injectable, The Compounding Pharmacy of America,… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Morphine 15 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | MEGA-BURN IV Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Tri-Mix AT-1 (8 mg/2 mg/0.2 mg) Injectable, The Compounding Pharmacy of America,… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Tri-Mix (37.5/2/20) (MFG) Injectable, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Cholecalciferol 50,000 IU/ml Injectable, Vial, Sterile, Refrigerate, The Compounding… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | HCG 2,500 IU/ml + Methylcobalamin 500 mcg/ml, Injection, Multi-Dose Vial, Sterile,… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Sermorelin 1000 mcg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, DO NOT SHAKE,… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | HCG 4,000 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding Pharmacy… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Hydromorphone 10 mg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Testosterone Cypionate 200 mg/ml Anastrazole 0.5 mg/ml Injection, Multi-Dose Vial,… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Morphine 70 mg/ml + Clonidine 1,100 mcg/ml Solution, Sterile-Preservative Free, The… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Estradiol 20 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Tri-Mix ST2/LIDO2/PGE2 0.2/0.1/0.04, Injectable, The Compounding Pharmacy of America,… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Testosterone 25 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Tri-Mix (17.7/0.59/6) (MFG) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Nandrolone Decanoate 200 mg/ml Injection, ml Multi-Dose Vial, Sterile, Room Temperature,… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | HCG 2,000 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding Pharmacy… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Testosterone 37.5 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Estradiol 8 mg, Sterile Pellet, The Compounding Pharmacy of America, Inc., Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Morphine 60 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Hydromorphone 30 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Estradiol 18 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | MEGA-BURN Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Tri-Mix T-50/PGE 2/LIDO 2 0.03/0.18/0.09 Injectable, The Compounding Pharmacy of America,… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Lipotropic B-12 II* + Lidocaine Injection, Multi-Dose Vial, Sterile, Room Temperature,… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Morphine 50 mg/ml + Fentanyl 10,000 mcg/ml + Bupivacaine 25 mg/ml, Solution, Sterile,… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Methylcobalamin 4,000 mcg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Testosterone Cypionate 220 mg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature,… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Fentanyl 7,000 mcg/ml + Bupivacaine 6 mg/ml + Clonidine 40 mcg/ml Intrathecal Solution,… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Tri-Mix SUPER (28 mg/0.9 mg/37 mcg) Injectable, Sterile Keep Frozen, The Compounding… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Lipo-B MMC I (SULFUR FREE) Injectable, Multi-Dose Vial, Sterile, Room Temperature, The… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Magnesium Chloride 200 mg/ml (20%) Injection, Multi-Dose Vial, Sterile, Refrigerate, The… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Tri-Mix ST9A (30 mg/2 mg/80 mcg) Injectable, The Compounding Pharmacy of America,… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Testosterone 87.5 mg Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Hyaluronic Acid Sodium 35 mg/ml + Lidocaine HCl 3 mg/ml Injection, ml Syringe, Sterile,… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Methionine 25 mg/ml + Inositol 50 mg/ml + Choline 25 mg/ml Injectable, Multi-Dose Vial,… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Fentanyl 5,000 mcg/ml + Baclofen 250 mcg/ml Intrathecal Solution, Sterile - Preservative… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Tri-Mix (22.5/0.83/8.3) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Hydromorphone 0.25 mg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Morphine 50 mg/ml + Ropivacaine 5 mg/ml +Baclofen 20 mcg/ml Solution, Sterile,… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Estradiol 50 mg, Sterile Pellet, The Compounding Pharmacy of America, Inc., Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Alprostadil 100 mcg/ml Injection, Sterile, Keep Frozen, The Compounding Pharmacy of… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Myers Cocktail Injection, Sterile, Refrigerate, The Compounding Pharmacy of America,… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Polidocanol 1% Injection, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | HCG 625 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, 40 DAY KIT, The… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Cyanocobalamin 1,000 mcg/ml + B-Complex 500 mg/ml, ml, Multi-Dose Vial, Sterile, Room… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Morphine 20 mg/ml + Clonidine 400 mcg/ml Solution Sterile-Preservative Free, The… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |
| Class II | September 23, 2015 | Vitatrim Injection, Multi-Dose Vial, Sterile, Keep Frozen, The Compounding Pharmacy of… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | The Compounding Pharmacy of America | Terminated |