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 | October 9, 2019 | Methionine 750 mg / Inositol 1,500 mg / Choline Chloride 1,500 mg / Pyridoxine HCl 1,500… | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc | Terminated |
| Class II | October 9, 2019 | Cyclopentolate HCl 1% (10 mg/mL) / Phenylephrine HCl 2.5% (25 mg/mL) / Tropicamide 1% (10… | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc | Terminated |
| Class II | October 9, 2019 | C-DEXAMETHASONE 24MG/ML INJ SOLUTION, packaged in 1 mL single dose vials, Rx only,… | Lack of Assurance of Sterility: product sterility cannot be guaranteed. | Colonia Care Pharmacy | Terminated |
| Class II | October 9, 2019 | SUCCinylcholine Chloride (PF), 100 mg / 5 mL (20 mg/mL), 5 mL Fill in a 6 mL Single Dose… | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc | Terminated |
| Class II | October 9, 2019 | SUCCinylcholine Chloride (PF), 140 mg/7 mL (20 mg/mL), 7 mL Fill in a 12 mL Single Dose… | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc | Terminated |
| Class II | October 9, 2019 | Sermorelin Acetate, 3 mg/mL/GHRP6, 1.8 mg/mL/GHRP2, 1.8 mg/mL, 3 mL… | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc | Terminated |
| Class II | October 9, 2019 | L-Asparaginase Lyophilized, 10,000 International Units/Vial, For IV / IM / SC Use, Rx… | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc | Terminated |
| Class II | October 9, 2019 | Ketamine in 0.9% Sodium Chloride (PF) 50 mg/ 5mL (10 mg/mL) 5 mL fill in a 6 mL Single… | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc | Terminated |
| Class II | October 9, 2019 | C-PAPAV/PHENTOL/PGE1 30MG/1MG/30MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmacy, 515… | Lack of Assurance of Sterility: product sterility cannot be guaranteed. | Colonia Care Pharmacy | Terminated |
| Class II | October 9, 2019 | Cyclopentolate HCl 1% (10 mg/mL) / Phenylephrine HCl 10% (100 mg/mL) / Tropicamide 1% (10… | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc | Terminated |
| Class II | October 9, 2019 | LIDOcaine HCl 1% (PF) 50 mg/5 mL (10 mg/mL), 5 mL Fill in a 6 mL Single Dose Syringe, Rx… | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc | Terminated |
| Class II | October 9, 2019 | NORepinephrine in 0.9% Sodium Chloride (PF), 250 mL IV bag, 4 mg/250 mL (0.016 mg/mL), Rx… | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc | Terminated |
| Class II | October 9, 2019 | Norepinephrine added to 5% Dextrose (PF), 250 mL IV bag, 8 mg/250 mL (0.032 mg/mL), Rx… | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc | Terminated |
| Class II | October 9, 2019 | C-UREA 40% BLADDER INSTILL, 30 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave.,… | Lack of Assurance of Sterility: product sterility cannot be guaranteed. | Colonia Care Pharmacy | Terminated |
| Class II | October 9, 2019 | C-METHYLCOBALAMIN 25MG/ML INJECTION PFS, packaged in 0.3 mL, 0.5 mL, 1 mL, and 3 mL… | Lack of Assurance of Sterility: product sterility cannot be guaranteed. | Colonia Care Pharmacy | Terminated |
| Class II | October 9, 2019 | Human Chorionic Gonadotropin 20,000 Units/Vials Lyophilized For SC/IM Use, Rx Only, KRS… | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc | Terminated |
| Class II | October 9, 2019 | C-PAPAV/PHENTOL/PGE1 30MG/2MG/20MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmacy, 515… | Lack of Assurance of Sterility: product sterility cannot be guaranteed. | Colonia Care Pharmacy | Terminated |
| Class II | October 9, 2019 | fentaNYL Citrate in 0.9% Sodium Chloride (PF) 1,000 mcg/100 mL (10 mcg/mL) 100 mL Fill in… | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc | Terminated |
| Class II | October 9, 2019 | Vitamin 5 B, 30 mL Vial For IM Use, Rx Only, KRS Global Biotechnology 791 Park of… | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc | Terminated |
| Class II | October 9, 2019 | PHENYephrine HCl in 0.9% Sodium Chloride (PF) (Contains Sulfites). 30 mg/250 mL (0.12… | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc | Terminated |
| Class II | October 9, 2019 | C-PHENOL/COTTONSEED OIL INJ 5%, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman… | Lack of Assurance of Sterility: product sterility cannot be guaranteed. | Colonia Care Pharmacy | Terminated |
| Class II | October 9, 2019 | NEOstigmine Methylsulfate (PF), 3 mg/3 mL (1 mg/mL), 3 mL Single Dose Syringe, Rx Only,… | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc | Terminated |
| Class II | October 9, 2019 | C-MB12 NAC 13MG/48MG/ML INJ SOLN, 0.29 mL in a 0.3 mL syringe, Rx only, Colonia Care… | Lack of Assurance of Sterility: product sterility cannot be guaranteed. | Colonia Care Pharmacy | Terminated |
| Class II | October 9, 2019 | Isoproterenol HCL (PF) in D5W, 200 mcg / 50 mL (4 mcg/mL), 50 mL IV Bag, Single Dose… | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc | Terminated |
| Class II | October 9, 2019 | ePHEDrine Sulfate in 0.9% Sodium Chloride (PF) 50 mg/10 mL (5 mg/mL) 10 mL Fill in a 12… | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc | Terminated |
| Class II | October 9, 2019 | Phenylephrine HCl 1.5% (15 mg/mL) Lidocaine HCl 1% (10 mg/mL) (PF) (Sulfite Free)… | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc | Terminated |
| Class II | October 9, 2019 | C-MB12/HB12 5MG/5MG/ML INJ SOLN, 0.9 mL in a 3 mL syringe, Rx only, Colonia Care… | Lack of Assurance of Sterility: product sterility cannot be guaranteed. | Colonia Care Pharmacy | Terminated |
| Class II | October 9, 2019 | PHENYLephrine HCl in 0.9% Sodium Chloride (PF), 1 mg / 10 mL (0.1 mg/mL), 10 mL Fill in a… | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc | Terminated |
| Class II | October 9, 2019 | Sodium Bicarbonate 8.4%, 4,200 mg / 50 mL 50 mEq / 50 mL (84 mg/mL) (1 mEq/mL), 50 mL… | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc | Terminated |
| Class II | October 9, 2019 | Quadmix #13A (Prostaglandin E1-0.3 mg / Papaverine HCl-200 mg / Phentolamine Mesylate-30… | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc | Terminated |
| Class II | October 9, 2019 | Human Chorionic Gonadotropin 11,000 Units/Vials Lyophilized For SC/IM Use, Rx Only, KRS… | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc | Terminated |
| Class II | October 9, 2019 | Vitamin B1/B2/B3/B6/HYDROXOCOBALAMIN 66/1.33/66/66/0.66 mg/mL (PF), For IV Use, 3 mL fill… | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc | Terminated |
| Class II | October 9, 2019 | Magnesium Chloride Hexahydrate 82.5 mg/mL; Calcium Gluconate 30 mg/mL (PF), For IV Use,… | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc | Terminated |
| Class II | October 9, 2019 | OxyTOCIN in 0.9% Sodium Chloride Solution (PF), 30 Units / 500 mL (0.06 Units / mL)… | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc | Terminated |
| Class II | October 9, 2019 | L-Carnitine 27 mL in a 30 mL Vial, 4,590 mg/27 mL (170 mg/mL) Rx Only, KRS Global… | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc | Terminated |
| Class II | October 9, 2019 | Hydroxocobalamin 10 mg/20 mL (0.5 mg/mL) 20 mL fill in a 30 mL Vial, Rx Only, KRS Global… | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc | Terminated |
| Class II | October 9, 2019 | C-PAPAV/PHENTOL/PGE1 10MG/1MG/10MCG/ML, packaged in a) 5 mL and b) 10 mL vials, Rx only,… | Lack of Assurance of Sterility: product sterility cannot be guaranteed. | Colonia Care Pharmacy | Terminated |
| Class II | October 9, 2019 | C-HYDROXOCOBALAMIN 25 MG/ML INJECTION SOLUTION, 1 mL syringe, Rx only, Colonia Care… | Lack of Assurance of Sterility: product sterility cannot be guaranteed. | Colonia Care Pharmacy | Terminated |
| Class II | October 9, 2019 | Methylcobalamin 30 mL Vial-For SC / IM / IV Use, 30 mg / 30 mL (1 mg / mL) Rx Only, KRS… | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc | Terminated |
| Class II | October 9, 2019 | C-PAPAV/PHENTOL/PGE1 18MG/0.6MG/5.8MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmacy, 515… | Lack of Assurance of Sterility: product sterility cannot be guaranteed. | Colonia Care Pharmacy | Terminated |
| Class II | October 9, 2019 | Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 tablets per bottle,… | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product… | Torrent Pharma Inc. | Ongoing |
| Class II | October 9, 2019 | Losartan Potassium /Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 tablets per bottle,… | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product… | Torrent Pharma Inc. | Ongoing |
| Class II | October 9, 2019 | Phenylephrine Hydrochloride Ophthalmic Solution, USP, 2.5%, 15 mL bottle, Rx only, Mfd.… | Lack of Assurance of Sterility: Out of specification results for container closure test which cannot guarantee the… | Akorn, Inc. | Terminated |
| Class II | October 9, 2019 | VIVITROL Vivitrol (naltrexone for extended-release injectable suspension) 380 mg/vial. Each Carton… | Labeling: Not Elsewhere Classified. Drug product kit recalled due to 1 inch needles being placed in the 1 1/2 inch… | Alkermes, Inc. | Terminated |
| Class I | October 2, 2019 | Natpara (parathyroid hormone) for Injection, 75 mcg, 2 pack medication cartridges, Rx… | Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing | Shire Human Genetic Therapies, Inc. | Terminated |
| Class I | October 2, 2019 | Natpara (parathyroid hormone) for Injection, 50 mcg, 2 pack medication cartridges, Rx… | Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing | Shire Human Genetic Therapies, Inc. | Terminated |
| Class I | October 2, 2019 | Quinacrine Dihydrochloride (98.25%), bulk API product, packaged in a) 500 g NDC#… | Label Mix-Up: Product labeled as Quinacrine Dihydrochloride; however, after testing, identified as Artemisinin. | Darmerica, LLC | Terminated |
| Class I | October 2, 2019 | Natpara (parathyroid hormone) for Injection, 100 mcg, 2 pack medication cartridges, Rx… | Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing | Shire Human Genetic Therapies, Inc. | Terminated |
| Class I | October 2, 2019 | Natpara (parathyroid hormone) for Injection, 25 mcg/dose, 2 pack cartridges, Rx only, For… | Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing | Shire Human Genetic Therapies, Inc. | Terminated |
| Class II | October 2, 2019 | Cisplatin Active Pharmaceutical Ingredient, Johnson Matthey Pharmaceutical Materials 2003… | cGMP Deviations: Potential glass contamination | Johnson Matthey Inc. | Terminated |
| Class II | October 2, 2019 | Oxaliplatin Active Pharmaceutical Ingredient, Johnson Matthey Pharmaceutical Materials… | cGMP Deviations: Potential glass contamination | Johnson Matthey Inc. | Terminated |
| Class II | October 2, 2019 | Fentanyl Citrate Active Pharmaceutical Ingredient, Johnson Matthey Pharmaceutical… | cGMP Deviations: Potential glass contamination | Johnson Matthey Inc. | Terminated |
| Class III | October 2, 2019 | minolira (minocycline hydrochloride) extended-release tablets 135 mg* Physician Sample… | Failed Dissolution Specifications: | EPI Health, LLC | Terminated |
| Class II | October 2, 2019 | Fexofenadine HCl Tablets, 180 mg, Pkg Size 90, Mfg: Aurohealth LLC, Repackaged by… | Failed Impurities/Degradation Specifications | Preferred Pharmaceuticals, Inc | Terminated |
| Class II | October 2, 2019 | Lidocaine Hydroclhoride Jelly USP, 2%, 30 mL tubes, Rx Only, Sterile, Manufactured by:… | cGMP Deviations: firm reported finding metal particulate matter in the filling room near the tube feeder during the… | Akorn, Inc. | Terminated |
| Class III | October 2, 2019 | ethosuximide capsules, USP, 250 mg, 100-count bottle, Rx Only, Distributed by: Greenstone… | Labeling: Incorrect or Missing Lot and/or Exp Date. The expiry date on the product label is incorrect. The label states… | Pfizer Inc. | Terminated |
| Class III | October 2, 2019 | Zarontin (ethosuximide capsules, USP) 250 mg, 100-count bottle, Rx Onl,y Made in… | Labeling: Incorrect or Missing Lot and/or Exp Date. The expiry date on the product label is incorrect. The label states… | Pfizer Inc. | Terminated |
| Class II | October 2, 2019 | Nucala (mepolizumab) Injection, 100 mg/mL Prefilled Syringe, Single-Dose, For… | Temperature Abuse; Product stored and shipped outside of labeled storage requirements. | Cardinal Health dba Specialty Pharmaceutical Services | Terminated |
| Class II | September 25, 2019 | PRE-TAT (lidocaine) 3 in 1 Pre Tattoo Prep With Lidocaine Cream, 4%, packaged in a) 1 OZ… | Microbial Contamination of Non-Sterile Products: products were found to be contaminated and above specification for… | Ridge Properties, LLC | Terminated |
| Class II | September 25, 2019 | Allergy (Fexofenadine Hydrochloride) Tablets USP, 180 mg, 30-count bottles, Distributed… | Failed Impurities/Degradation Specifications | Aurolife Pharma, LLC | Terminated |
| Class II | September 25, 2019 | Allergy Relief (Fexofenadine HCl) tablets USP, 180 mg, 15-count cartons, equate,… | Failed Impurities/Degradation Specifications | Aurolife Pharma, LLC | Terminated |
| Class II | September 25, 2019 | Soothing Sore Relief (lidocaine) Cream, 4%, packaged in a) 1 OZ (NDC 69804-074-05), b) 2… | Superpotent Drug: products were found to be contaminated and above specification for lidocaine assay. | Ridge Properties, LLC | Terminated |
| Class II | September 25, 2019 | Fexofenadine Hydrochloride Tablets USP, 180 mg, packaged in a) 15-count cartons (NDC… | Failed Impurities/Degradation Specifications | Aurolife Pharma, LLC | Terminated |
| Class II | September 25, 2019 | Wal-Fex (Fexofenadine Hydrochloride) Tablets USP, 180 mg, 5-count cartons, Distributed… | Failed Impurities/Degradation Specifications | Aurolife Pharma, LLC | Terminated |
| Class II | September 25, 2019 | Allergy (Fexofenadine Hydrochloride) Tablets USP, 180 mg, 30-count cartons, DISCOUNT drug… | Failed Impurities/Degradation Specifications | Aurolife Pharma, LLC | Terminated |
| Class II | September 25, 2019 | Allergy Relief (fexofenadine hydrochrloride) tablets, 180 mg, 5-count carton, Good… | Failed Impurities/Degradation Specifications | Aurolife Pharma, LLC | Terminated |
| Class II | September 25, 2019 | Allergy Relief (Fexofenadine Hydrochrloride) Tablets USP, 180 mg, packaged in a) 15-count… | Failed Impurities/Degradation Specifications | Aurolife Pharma, LLC | Terminated |
| Class II | September 25, 2019 | Fexofenadine Hydrochrloride Tablets USP, 180 mg, 100-count bottle, Distributed by:… | Failed Impurities/Degradation Specifications | Aurolife Pharma, LLC | Terminated |
| Class II | September 25, 2019 | Superior Pain & Itch Relief (lidocaine) Liquid Gel, 4%, packaged in a) 1 Oz (NDC… | Superpotent Drug: products were found to be contaminated and above specification for lidocaine assay. | Ridge Properties, LLC | Terminated |
| Class II | September 25, 2019 | fexofenadine hydrochloride tablets USP, 180 mg, 150-count bottle, Member's Mark,… | Failed Impurities/Degradation Specifications | Aurolife Pharma, LLC | Terminated |
| Class II | September 25, 2019 | Fexofenadine HCL Tablets USP, 180 mg, 500's BRITE STOCK; Manufactured for: Aurohealth… | Failed Impurities/Degradation Specifications | Aurolife Pharma, LLC | Terminated |
| Class II | September 25, 2019 | Soothing Sore Relief (lidocaine) Liquid Gel, 4%, packaged in a) 1 Oz (NDC 69804-077-14),… | Superpotent Drug: products were found to be contaminated and above specification for lidocaine assay. | Ridge Properties, LLC | Terminated |
| Class II | September 25, 2019 | PRE-TAT (lidocaine) 3 in 1 Pre Tattoo Prep With Lidocaine Liquid Gel, 4%, packaged in a)… | Microbial Contamination of Non-Sterile Products: products were found to be contaminated and above specification for… | Ridge Properties, LLC | Terminated |
| Class II | September 25, 2019 | Fexofenadine Hydrochloride Tablets USP, 180 mg, packaged in a) 30-count carton (NDC… | Failed Impurities/Degradation Specifications | Aurolife Pharma, LLC | Terminated |
| Class II | September 25, 2019 | Superior Pain & Itch Relief (lidocaine) Cream, 4%, packaged in a) 1 OZ (NDC… | Superpotent Drug: products were found to be contaminated and above specification for lidocaine assay. | Ridge Properties, LLC | Terminated |
| Class II | September 25, 2019 | Oxcarbazepine Oral Suspension, USP, 300 mg/5 mL, 250 mL per bottle, Rx Only, Distr. by:… | Failed Impurities/Degradation Specificattion | West-Ward Columbus Inc | Terminated |
| Class II | September 25, 2019 | Anagrelide Anagrelide Capsules, USP, 0.5 mg, 100-count bottle, Rx only, Manufactured in India for:… | Failed Impurities/Degradation Specifications: High Out Of Specification results for impurities detected during routine… | Torrent Pharma Inc. | Terminated |
| Class III | September 18, 2019 | Pramipexole Dihydrochloride Pramipexole Dihydrochloride Tablets 0.125 mg,90-count bottle, Rx Only, Manufactured for:… | Subpotent Drug: Out of specification result during stability study in Pramipexole Dihydrochloride Tablets 0.125 mg | Macleods Pharma Usa Inc | Terminated |
| Class III | September 18, 2019 | Gatifloxacin Ophthalmic Solution 0.5%, 2.5 mL per bottle, Rx Only, Mfd. for: Mylan… | Failed Impurities/Degradation Specifications:OOS for unknown impurity. | Mylan Pharmaceuticals Inc. | Terminated |
| Class II | September 18, 2019 | 5% Acetyl-L-Cysteine Ophthalmic Solutions, dispensed in a) 5ml , b) 10ml dropper bottles | Lack of Processing Controls: | Compounded Solutions in Pharmacy | Terminated |
| Class II | September 18, 2019 | 10% Acetyl-L-Cysteine Ophthalmic Solutions, dispensed in a) 5ml, b) 10ml c) 15 ml,… | Lack of Processing Controls: | Compounded Solutions in Pharmacy | Terminated |
| Class II | September 18, 2019 | AVKARE Fexofenadine Hydrochloride Tablets USP Antihistamine 180 mg, 500 Tablets per… | Failed Stability Specifications. | AVKARE Inc. | Terminated |
| Class II | September 18, 2019 | 20% Acetyl-L-Cysteine Ophthalmic Solutions, dispensed in 3ml dropper bottle. | Lack of Processing Controls: | Compounded Solutions in Pharmacy | Terminated |
| Class II | September 18, 2019 | Bevacizumab, 2.5 mg/0.1 mL, Norm-Ject Syringe Intravitreal Injection, Single use only, Rx… | Lack of assurance of sterility. | Pacifico National, Inc. dba AmEx Pharmacy | Terminated |
| Class II | September 18, 2019 | Bevacizumab, 1.25 mg/0.05 mL, 31G MJ Syringe Intravitreal Injection, Single use only, Rx… | Lack of assurance of sterility. | Pacifico National, Inc. dba AmEx Pharmacy | Terminated |
| Class I | September 18, 2019 | Milk of Magnesia USP, 2400 mg/30 mL, Magnesium Hydroxide 2400 mg, 30 mL unit dose cups,… | Microbial Contamination of Non-Sterile Products: product failed bioburden testing for Total Aerobic Microbial Count. | Plastikon Healthcare LLC | Terminated |
| Class III | September 18, 2019 | Lamivudine Tablets, USP, 150 mg, 30 (3x10) count Unit Dose Blisters Carton, NDC… | Labeling: Incorrect or Missing Package Insert; an error in the Dosage Forms and Strengths section of the insert that… | American Health Packaging | Terminated |
| Class II | September 18, 2019 | Bacteriostatic Water Bacteriostatic Water for Injection, USP, 30 mL vials, Rx only, Mfd. for: Hospira, Inc.,… | Lack of Assurance of Sterility | Pfizer Inc. | Terminated |
| Class III | September 4, 2019 | Eptifibatide Injection, a) 20 mg/10 mL (2 mg/mL),10 mL Single Use Vial, NDC 17478-902-10,… | Failed Impurities/Degradation Specifications: Out of Specification (OOS) for known impurity, D-aspartic acid. | Akorn, Inc. | Terminated |
| Class III | September 4, 2019 | Eptifibatide Injection, 75 mg/100 mL (0.75 mg/mL), 100 mL Single-use Vial, For… | Short Fill: fill volume was out of specification at 94 mL (specification: no less than 100 mL) and Failed… | Akorn, Inc. | Terminated |
| Class III | September 4, 2019 | Eptifibatide Injection, 75 mg/100 mL (0.75 mg/mL), 100 mL Single-use Vial, For… | Failed Impurities/Degradation Specifications: Out of Specification (OOS) for known impurity, D-aspartic acid. | Akorn, Inc. | Terminated |
| Class II | September 4, 2019 | RELPAX (eletriptan HBr) tablets, 40 mg, packaged in a) 6-count (1 card x 6 tablets) per… | Microbial Contamination of Non-Sterile Products: contamination with Burkholderia and Pseudomonas. | Pfizer Inc. | Terminated |
| Class III | September 4, 2019 | Simvastatin Simvastatin Tablets, USP 40 mg. Rx Only 1000 Count Bottles Manufactured by: Aurolife… | Labeling; Incorrect or Missing Lot and/or Exp Date; some bottles labeled with lot number 05318054B instead of 05318034B | Aurobindo Pharma USA Inc. | Terminated |
| Class II | September 4, 2019 | VIVITROL Vivitrol (naltrexone for extended-release injectable suspension) 380 mg/vial. Each Carton… | Labeling: Not Elsewhere Classified. Drug product kit recalled due to 1 inch needles being placed in the 1 1/2 inch… | Alkermes Inc | Terminated |
| Class II | August 28, 2019 | Clear Eyes Redness Relief Hand Pocket Pal Tray Display; each display (UPC 6 78112 25418… | CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the… | Medtech Products, Inc. | Terminated |
| Class II | August 28, 2019 | Clear Eyes Assorted IRC Display; each display contains 6 each of a) Clear eyes REDNESS… | CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the… | Medtech Products, Inc. | Terminated |
| Class II | August 28, 2019 | Clear Eyes Maximum Itchy Eye Relief Sidekick Floor Stand Display; each display (case UPC… | CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the… | Medtech Products, Inc. | Terminated |
| Class II | August 28, 2019 | Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%) eye drops,… | CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the… | Medtech Products, Inc. | Terminated |
| Class II | August 28, 2019 | Bexarotene Bexarotene Capsules, 75 mg, 100 capsules per bottle, Rx Only, Manufactured for:… | Failed Dissolution Specifications | Upsher Smith Laboratories, Inc. | Terminated |
| Class II | August 28, 2019 | Clear eyes MAXIMUM REDNESS RELIEF (Glycerin 0.5%, Naphazoline hydrochloride 0.03%) eye… | CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the… | Medtech Products, Inc. | Terminated |
| Class II | August 28, 2019 | Clear eyes MAXIMUM ITCHY EYE RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%,… | CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the… | Medtech Products, Inc. | Terminated |
| Class II | August 28, 2019 | Clear Eyes Redness Relief Club Pack Display; each display contains 18 3-Pack bottles (UPC… | CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the… | Medtech Products, Inc. | Terminated |
| Class II | August 28, 2019 | Clear Eyes Maximum Redness Relief Club Pack Display; each display contains 18 3-Pack… | CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the… | Medtech Products, Inc. | Terminated |
| Class II | August 28, 2019 | Clear Eyes Maximum Itchy Eye Relief Sidekick Floor Stand Display; each display contains… | CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the… | Medtech Products, Inc. | Terminated |
| Class II | August 28, 2019 | Clear Eyes Redness Relief Handy Pocket Pal Club Pak Display; each display (case UPC… | CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the… | Medtech Products, Inc. | Terminated |
| Class II | August 28, 2019 | Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%) eye drops,… | CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the… | Medtech Products, Inc. | Terminated |
| Class II | August 28, 2019 | Clear Eyes Assorted Sidekick Floor Stand Display; each display contains 6 each of a)… | CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the… | Medtech Products, Inc. | Terminated |
| Class II | August 28, 2019 | Ketamine 50 mg/5 mL in 0.9% Sodium Chloride Injection for IV or IM Use (concentration =… | Lack of Assurance of Sterility. | SCA Pharmaceuticals, LLC | Terminated |
| Class II | August 28, 2019 | Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%) eye drops,… | CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the… | Medtech Products, Inc. | Terminated |
| Class II | August 28, 2019 | Clear Eyes Maximum Redness and Itchy Eye Relief Sidekick Display; each display contains… | CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the… | Medtech Products, Inc. | Terminated |
| Class II | August 21, 2019 | Adcetris 96 MG/100 ML NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn,… | Lack of Assurance of Sterility | Infusion Options, Inc. | Terminated |
| Class II | August 21, 2019 | Cisplatin 40 MG / 500 ml NS IVPB WITH Mannitol 40 G; Cisplatin 80 MG / 250 ml 0.9% NACL;… | Lack of Assurance of Sterility | Infusion Options, Inc. | Terminated |
| Class II | August 21, 2019 | Gemcitabine 1910 MG / 250 ML NS IVPB; Gemcitabine 1140 MG / 250 ML NS 0.9% IVPB;… | Lack of Assurance of Sterility | Infusion Options, Inc. | Terminated |
| Class II | August 21, 2019 | CARFILZOMIB 65 MG IN 50 ML D5W IVPB; CARFILZOMIB 75 MG IN 50 ML D5W IVPB; CARFILZOMIB 50… | Lack of Assurance of Sterility | Infusion Options, Inc. | Terminated |
| Class II | August 21, 2019 | IFOSFAMIDE 9200 MG / 1 L NS IVPB WITH MESNA 9200 MG, Rx Only, Infusion Options, Inc. 5924… | Lack of Assurance of Sterility | Infusion Options, Inc. | Terminated |
| Class II | August 21, 2019 | RITUXAN 728 MG QS 728 mL 0.9% NACL IVPB; RITUXAN 560 MG / 306 ml 0.9% NACL; RITUXAN 562… | Lack of Assurance of Sterility | Infusion Options, Inc. | Terminated |
| Class II | August 21, 2019 | Oxytocin 60 units/1000 mL Lactated Ringers Intravenous Solution, Rx Only, Infusion… | Lack of Assurance of Sterility | Infusion Options, Inc. | Terminated |
| Class II | August 21, 2019 | CRYO-273 Cold Pain Relieving Gel Roll-On 3 FL. OZ. (89 mL) Distributed By: CRYO-273.com… | CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified… | US Pharmaceuticals Inc. | Terminated |
| Class II | August 21, 2019 | Cool Hot Ice Analgesic Gel, 8 oz (227 g) Distributed by: Unipack Inc. Pittsburg, PA… | CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified… | US Pharmaceuticals Inc. | Terminated |
| Class II | August 21, 2019 | Kool Comfort Cooling Pain Relief, 5% Menthol, Packaged in a) 3 OZ./85 g (UPC 0 52301… | CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified… | US Pharmaceuticals Inc. | Terminated |
| Class II | August 21, 2019 | Children Glycerin Suppositories Laxative for ages 2 to 5. Package Size… | CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified… | US Pharmaceuticals Inc. | Terminated |
| Class II | August 21, 2019 | Adult Glycerin Suppositories, Package Size 50-count suppositories, Distributed By:… | CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified… | US Pharmaceuticals Inc. | Terminated |
| Class II | August 21, 2019 | Eczema Lotion Hydrocortisone 1% / Anti-Itch Lotion, 3.5 oz (99.2 g) Distributed By:… | CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified… | US Pharmaceuticals Inc. | Terminated |
| Class II | August 21, 2019 | Aspirin and Extended-release Dipyridamole Capsules, 25 mg/200 mg, 20 capsules per carton… | Failed Impurities/Degradation Specifications; out of specification result for an unknown impurity in stability samples. | American Health Packaging | Terminated |
| Class II | August 21, 2019 | CVS Therapeutic Menthol Gel, 8 FL OZ (227 g) Distributed by: CVS Pharmacy, Inc. One CVS… | CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified… | US Pharmaceuticals Inc. | Terminated |
| Class II | August 21, 2019 | Wonder Freeze Pain Releiving Gel with ILEX, Menthol 5%, packaged in a) 3 OZ /85 g (UPC 0… | CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified… | US Pharmaceuticals Inc. | Terminated |
| Class II | August 21, 2019 | Adult Glycerin Suppositories, Package Size 100-count suppositories, Distributed By:… | CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified… | US Pharmaceuticals Inc. | Terminated |
| Class II | August 21, 2019 | CVS Health Glycerin Suppositories, 50-count box, Distributed by: CVS Pharmacy, Inc. One… | CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified… | US Pharmaceuticals Inc. | Terminated |
| Class II | August 21, 2019 | CRYO-273 Cold Pain Relieving Gel 128 FL. OZ. Distributed By: CRYO-273.com Tampa, FL… | CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified… | US Pharmaceuticals Inc. | Terminated |
| Class II | August 21, 2019 | Tamsulosin Hydrochloride Tamsulosin Hydrochloride Capsules, USP 0.4 mg Rx only a) 100 count (NDC 33342-159-11), b)… | Failed Dissolution Specifications | Macleods Pharma Usa Inc | Terminated |
| Class II | August 21, 2019 | CVS Health Glycerin Suppositories, 100- count box, Distributed by:Distributed by: CVS… | CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified… | US Pharmaceuticals Inc. | Terminated |
| Class II | August 21, 2019 | Carbamazepine, Extended-Release Tablets, USP, 400 mg, 30 Tablets (3 blister cards x 10… | Failed Dissolution Specifications | American Health Packaging | Terminated |
| Class II | August 21, 2019 | FERRIC CARBOXYMALTOSE 750mg/50ml NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave,… | Lack of Assurance of Sterility | Infusion Options, Inc. | Terminated |
| Class II | August 21, 2019 | SOLIRIS 1200 MG QS 240 ML NACL0.9% IVPB; SOLIRIS 900 MG QS 180 ML NACL 0.9% IVPB, Rx… | Lack of Assurance of Sterility | Infusion Options, Inc. | Terminated |
| Class II | August 21, 2019 | ADO-TRASTUZUMAB 210 MG/250 ml NS; ADO-TRASTUZUMAB E 213 MG / 250 ML NS; ADO-TRASTUZUMAB… | Lack of Assurance of Sterility | Infusion Options, Inc. | Terminated |
| Class II | August 21, 2019 | Durvalumab 651 mg/ 250 ml NS IVPB; Durvalumab 650 mg/ 250 ml NS IVPB, Rx Only, Infusion… | Lack of Assurance of Sterility | Infusion Options, Inc. | Terminated |
| Class II | August 21, 2019 | Doxorubicin Liposomal 71 MG / 250 ML D5W IVPB; Doxorubicin Liposomal 66 MG/250 ML D5W, Rx… | Lack of Assurance of Sterility | Infusion Options, Inc. | Terminated |
| Class II | August 21, 2019 | CETUXIMAB 335 MG / 167.5 ML IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave,… | Lack of Assurance of Sterility | Infusion Options, Inc. | Terminated |
| Class II | August 21, 2019 | OXALIPLATIN 145 MG /250 ML D5W IVPB; OXALIPLATIN 154 MG / 250 ML D5W IVPB; OXALIPLATIN… | Lack of Assurance of Sterility | Infusion Options, Inc. | Terminated |
| Class II | August 21, 2019 | PACLITAXEL PROTEIN 175 MG/100 ML NS IVPB; PACLITAXEL PROTEIN 190 MG/100 ML NS IVPB;… | Lack of Assurance of Sterility | Infusion Options, Inc. | Terminated |
| Class II | August 21, 2019 | ENTYVIO 300 MG /250 ML 0.9% NACL, Rx Only, Infusion Options, Inc. 5924 13the Ave,… | Lack of Assurance of Sterility | Infusion Options, Inc. | Terminated |
| Class II | August 21, 2019 | RAMUCIRUMAB 457 MG QS 250 ML NS IVPB; AMUCIRUMAB 1182 MG QS 250 ML NS IVPB; Rx Only,… | Lack of Assurance of Sterility | Infusion Options, Inc. | Terminated |
| Class II | August 21, 2019 | PERTUZUMAB 840 MG/250 ml0.9% NACL IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave,… | Lack of Assurance of Sterility | Infusion Options, Inc. | Terminated |
| Class II | August 21, 2019 | MITOMYCIN 10 MG /20 ML IVP SYRINGE, Rx Only, Infusion Options, Inc. 5924 13the Ave,… | Lack of Assurance of Sterility | Infusion Options, Inc. | Terminated |
| Class II | August 21, 2019 | BLEOMYCIN 18 UNITS / 100 ML NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave,… | Lack of Assurance of Sterility | Infusion Options, Inc. | Terminated |
| Class II | August 21, 2019 | NIVOLUMAB 480 MG / 100 ML NS IVPB; NIVOLUMAB 200 mg / 100 ML NS IVPB; NIVOLUMAB 165 mg /… | Lack of Assurance of Sterility | Infusion Options, Inc. | Terminated |
| Class II | August 21, 2019 | DOCETAXEL 60 MG / 250 ml D5W IVPB; DOCETAXEL 71 MG/ 250 ML NS IVPB; DOCETAXEL 155 MG/ 250… | Lack of Assurance of Sterility | Infusion Options, Inc. | Terminated |
| Class II | August 21, 2019 | LEUCOVORIN 560 MG / 250 ML NS IVPB; LEUCOVORIN 830 MG / 250 ml NS IVPB; LEUCOVORIN 300 MG… | Lack of Assurance of Sterility | Infusion Options, Inc. | Terminated |
| Class II | August 21, 2019 | PEMETREXED 910 MG QS 100 ML NS IVPB; PEMETREXED 940 mg QS 100 ml NS IVPB; PEMETREXED 1000… | Lack of Assurance of Sterility | Infusion Options, Inc. | Terminated |
| Class II | August 21, 2019 | BEVACIZUMAB 784 MG / 100 ML NS IVPB; BEVACIZUMAB 350 MG/100 ml NS IVPB; BEVACIZUMAB 425… | Lack of Assurance of Sterility | Infusion Options, Inc. | Terminated |
| Class II | August 21, 2019 | Etoposide 184 MG / 500 ml NS IVPB; Etoposide 176 MG/ 500 ml 0.9% NACL IVPB; Etoposide 170… | Lack of Assurance of Sterility | Infusion Options, Inc. | Terminated |
| Class II | August 21, 2019 | REMICADE 680 MG QS 250 ML 0.9% NACL IVPB; REMICADE 270 MG QS 250 ML 0.9% NACL IV;… | Lack of Assurance of Sterility | Infusion Options, Inc. | Terminated |
| Class II | August 21, 2019 | IRON SUCROSE 200 mg / 100 ML NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave,… | Lack of Assurance of Sterility | Infusion Options, Inc. | Terminated |
| Class II | August 21, 2019 | ALIMTA 785 mg QS 100 ml 0.9% NACL IVPB; ALIMTA 1000 mg QS 100 ml 0.9% NACL IVPB; Rx Only,… | Lack of Assurance of Sterility | Infusion Options, Inc. | Terminated |
| Class II | August 21, 2019 | Fluorouracil 560 MG / 11.2 ML IVP; Fluorouracil 3340 MG QS 92 ML 0.9% NACL; Fluorouracil… | Lack of Assurance of Sterility | Infusion Options, Inc. | Terminated |
| Class II | August 21, 2019 | HERCEPTIN 400 MG / 250 ML NS IVPB; HERCEPTIN 340 MG /250 ml 0.9% NACL IVPB; HERCEPTIN 553… | Lack of Assurance of Sterility | Infusion Options, Inc. | Terminated |
| Class II | August 21, 2019 | Cytarabine 128 MG/250 ML D5W IVPB; Cytarabine 20 MG / 1 ML SQ SYRINGE Cytarabine 70 MG QS… | Lack of Assurance of Sterility | Infusion Options, Inc. | Terminated |
| Class II | August 21, 2019 | PRESERVATIVE FREE 0.9% NACL 5 ML SYR, Rx Only, Infusion Options, Inc. 5924 13the Ave,… | Lack of Assurance of Sterility | Infusion Options, Inc. | Terminated |
| Class II | August 21, 2019 | Cisplatin 40 MG / 500 ml NS IVPB WITH Mannitol 40 G; Cisplatin 80 MG / 250 ml 0.9% NACL;… | Lack of Assurance of Sterility | Infusion Options, Inc. | Terminated |
| Class II | August 21, 2019 | PACLITAXEL ALBUMIN 185 mg /100 ml NS IVPB; PACLITAXEL ALBUMIN 160 MG / 100 ml NS IVPB;… | Lack of Assurance of Sterility | Infusion Options, Inc. | Terminated |
| Class II | August 21, 2019 | METHYLPREDNISOLONE 10 MG / 0.16 ML IVP, Rx Only, Infusion Options, Inc. 5924 13the Ave,… | Lack of Assurance of Sterility | Infusion Options, Inc. | Terminated |
| Class II | August 21, 2019 | DARZALEX 1008 MG / 500 ML NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave,… | Lack of Assurance of Sterility | Infusion Options, Inc. | Terminated |
| Class II | August 21, 2019 | DECITABINE 40 MG / 100 ml NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave,… | Lack of Assurance of Sterility | Infusion Options, Inc. | Terminated |
| Class II | August 21, 2019 | PEMBROLIZUMAB 200 MG / 100 ML NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave,… | Lack of Assurance of Sterility | Infusion Options, Inc. | Terminated |
| Class II | August 21, 2019 | OPDIVO 200 mg /100 ML NS VPB; OPDIVO 480 mg/100 ML NS IVPB, Rx Only, Infusion Options,… | Lack of Assurance of Sterility | Infusion Options, Inc. | Terminated |
| Class II | August 21, 2019 | AVASTIN 630 MG / 100 ML 0.9% NACL IVPB; AVASTIN 2.5 mg/ 0.1ML Syringe; AVASTIN 587.5… | Lack of Assurance of Sterility | Infusion Options, Inc. | Terminated |
| Class II | August 21, 2019 | INJECTAFER 720 MG in 100 ml NS IVPB; INJECTAFER 210 MG in 100 ml NS IVPB, Rx Only,… | Lack of Assurance of Sterility | Infusion Options, Inc. | Terminated |
| Class II | August 21, 2019 | IRINOTECAN 250 MG /500 ml D5W IVPB; IRINOTECAN 110 MG /250 ML D5W IVPB; IIRINOTECAN 250… | Lack of Assurance of Sterility | Infusion Options, Inc. | Terminated |
| Class II | August 21, 2019 | GAZYVA 100 MG IN 250 ML NS IVPB; GAZYVA 900 MG IN 250 ML NS IVPB, Rx Only, Infusion… | Lack of Assurance of Sterility | Infusion Options, Inc. | Terminated |
| Class II | August 21, 2019 | Sodium Chloride 0.9% 1 LITER WITH Potassium Chloride 20 mEq, Mannitol 12.5 G, Magnesium… | Lack of Assurance of Sterility | Infusion Options, Inc. | Terminated |
| Class II | August 21, 2019 | Abraxane 170 MG / 34 ML IVPB; Abraxane 200 MG / 40 ML IVPB; Abraxane 180 MG / 36 ML IVPB,… | Lack of Assurance of Sterility | Infusion Options, Inc. | Terminated |
| Class II | August 21, 2019 | DEXAMETHASONE 10 MG / 50 ML NS IVPB; DEXAMETHASONE 5 MG / 50 ML NS; DEXAMETHASONE 5 MG /… | Lack of Assurance of Sterility | Infusion Options, Inc. | Terminated |
| Class II | August 21, 2019 | PACLITAXEL 258 MG / 500 ML NS IVPB; PACLITAXEL 318 MG / 500 ML NS IVPB; PACLITAXEL 385 MG… | Lack of Assurance of Sterility | Infusion Options, Inc. | Terminated |
| Class II | August 21, 2019 | FOSAPREPITANT 150 mg/150 ml NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave,… | Lack of Assurance of Sterility | Infusion Options, Inc. | Terminated |
| Class II | August 21, 2019 | VINCRISTINE 1 MG /50 ML NS IVPB; VINCRISTINE 1.2 MG /50 ML NACL 0.9% IVPB; VINCRISTINE 1… | Lack of Assurance of Sterility | Infusion Options, Inc. | Terminated |
| Class II | August 21, 2019 | ORENCIA 750 mg QS 100 ml 0.9% NACL IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave,… | Lack of Assurance of Sterility | Infusion Options, Inc. | Terminated |
| Class II | August 21, 2019 | DACARBAZINE 680 MG in 250 ml NS; DACARBAZINE 675 MG in 250 ml NS, Rx Only, Infusion… | Lack of Assurance of Sterility | Infusion Options, Inc. | Terminated |
| Class II | August 21, 2019 | PANITUMUMAB 400 MG / 100 ml NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave,… | Lack of Assurance of Sterility | Infusion Options, Inc. | Terminated |
| Class II | August 21, 2019 | Doxorubicin 110 MG / 55 ML IVP SYRINGE; Doxorubicin 56 MG / 28 ML IVP SYRINGE;… | Lack of Assurance of Sterility | Infusion Options, Inc. | Terminated |
| Class II | August 21, 2019 | CARBOPLATIN 174 MG / 250ml NS IVPB; CARBOPLATIN 240 MG / 250 ML NS IVPB; CARBOPLATIN 750… | Lack of Assurance of Sterility | Infusion Options, Inc. | Terminated |
| Class II | August 21, 2019 | DARATUMUMAB 904 MG QS 500 ML NS IVPB; DARATUMUMAB 668 MG QS 1000 ML NS IVPB, Rx Only,… | Lack of Assurance of Sterility | Infusion Options, Inc. | Terminated |
| Class II | August 21, 2019 | RomiPLOStim 700 MCG/ 1.4 ML SQ SYR, Rx Only, Infusion Options, Inc. 5924 13the Ave,… | Lack of Assurance of Sterility | Infusion Options, Inc. | Terminated |
| Class II | August 21, 2019 | RITUXIMAB 575 MG / 250 ml 0.9% NACL IVPB; RITUXIMAB 675 MG / 250 ml 0.9% NACL IVPB;… | Lack of Assurance of Sterility | Infusion Options, Inc. | Terminated |
| Class II | August 21, 2019 | ERIBULIN 1.12 MG / 100 ML NS IVPB; ERIBULIN 1.87 MG / 100 ML NS IVPB; ERIBULIN 1.89 MG /… | Lack of Assurance of Sterility | Infusion Options, Inc. | Terminated |
| Class II | August 21, 2019 | DIPHENHYDRAMINE 25 MG/50 ML NS, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn,… | Lack of Assurance of Sterility | Infusion Options, Inc. | Terminated |
| Class II | August 21, 2019 | TOPOTECAN 1.24 MG / 100 ML NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave,… | Lack of Assurance of Sterility | Infusion Options, Inc. | Terminated |
| Class II | August 21, 2019 | Cyclophosphamide 840 MG / 250 ML NS IVPB; Cyclophosphamide 1112 MG / 250 ML NS IVPB;… | Lack of Assurance of Sterility | Infusion Options, Inc. | Terminated |
| Class II | August 21, 2019 | VINBLASTINE 10.9 MG / 100 ML D5W IVPB; VINBLASTINE 10.8 MG / 100 ML D5W IVPB, Rx Only,… | Lack of Assurance of Sterility | Infusion Options, Inc. | Terminated |
| Class II | August 21, 2019 | AZACITIDINE 125 MG / 5 ML SUB-Q SYRINGE; AZACITIDINE 75 MG (3 ML) SYRINGE, AZACITIDINE… | Lack of Assurance of Sterility | Infusion Options, Inc. | Terminated |
| Class II | August 21, 2019 | Fluorouracil 560 MG / 11.2 ML IVP Fluorouracil 3340 MG QS 92 ML 0.9% NACL Fluorouracil… | Lack of Assurance of Sterility | Infusion Options, Inc. | Terminated |
| Class II | August 21, 2019 | TRASTUZUMAB 427 MG / 250 ml NS IVPB; TRASTUZUMAB 531 MG / 250 ML NS IVPB; TRASTUZUMAB 276… | Lack of Assurance of Sterility | Infusion Options, Inc. | Terminated |
| Class II | August 21, 2019 | InFLIXimab 300 mg / 250 ml 0.9% NACL IVPB, Rx Only, Infusion Options, Inc. 5924 13the… | Lack of Assurance of Sterility | Infusion Options, Inc. | Terminated |
| Class II | August 21, 2019 | GRANISETRON 1000 MCG / 50 ML NS, Rx Only, Infusion Options, Inc. 5924 13the Ave,… | Lack of Assurance of Sterility | Infusion Options, Inc. | Terminated |
| Class II | August 21, 2019 | METHOTREXATE 25 MG / 1 ML IM SYR; METHOTREXATE 12 mg QS 5 ml PF 0.9% NACL; METHOTREXATE… | Lack of Assurance of Sterility | Infusion Options, Inc. | Terminated |
| Class II | August 21, 2019 | BORTEZOMIB 2.5 mg / 1 ML SQ SYRINGE; BORTEZOMIB 2.88 MG / 1.15 ML SQ SYRINGE; BORTEZOMIB… | Lack of Assurance of Sterility | Infusion Options, Inc. | Terminated |
| Class II | August 21, 2019 | ONDANSETRON 8 MG / 50 ml NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave,… | Lack of Assurance of Sterility | Infusion Options, Inc. | Terminated |
| Class II | August 21, 2019 | VELCADE 2.1 mg / 0.84 ml SQ SYRINGE; VELCADE 2.5 MG/ 1 ML SUB-Q SYRINGE; VELCADE 2.2 MG/… | Lack of Assurance of Sterility | Infusion Options, Inc. | Terminated |
| Class II | August 21, 2019 | PERJETA 420 MG/250 ml 0.9% NACL IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave,… | Lack of Assurance of Sterility | Infusion Options, Inc. | Terminated |
| Class II | August 21, 2019 | ATEZOLIZUMAB 1200 MG / 250 ML 0.9% NACL, Rx Only, Infusion Options, Inc. 5924 13the Ave,… | Lack of Assurance of Sterility | Infusion Options, Inc. | Terminated |
| Class II | August 21, 2019 | ERBITUX 770 MG/ 385 ML IVPB; ERBITUX 440 MG/ 220 ml IVPB; ERBITUX 850 MG/ 425 ml IVPB, Rx… | Lack of Assurance of Sterility | Infusion Options, Inc. | Terminated |
| Class II | August 21, 2019 | CALCIUM GLUCONATE 1 GM /100 ML NACL 0.9% IVPB, Rx Only, Infusion Options, Inc. 5924 13the… | Lack of Assurance of Sterility | Infusion Options, Inc. | Terminated |
| Class II | August 21, 2019 | Hydrocortisone Cream, Hydrocortisone 1% / Anti-Itch Cream, 1 OZ (28 g) tube. Distributed… | CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified… | US Pharmaceuticals Inc. | Terminated |
| Class II | August 21, 2019 | Adult Glycerin Suppositories, Package Size 25-count suppositories, Distributed By:… | CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified… | US Pharmaceuticals Inc. | Terminated |
| Class II | August 21, 2019 | Hydrocortisone Cream, Hydrocortisone 1% / Anti-Itch Cream, 2 OZ (56 g) tube. Distributed… | CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified… | US Pharmaceuticals Inc. | Terminated |
| Class II | August 21, 2019 | Soothe&Cool Protect Moisture Guard Skin Protectant, 3.5 oz. (99 g), tube, Manufactured… | CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified… | US Pharmaceuticals Inc. | Terminated |
| Class II | August 21, 2019 | Macrobid Macrobid Urinary Tract Anitbacterial, 100 mg, 100-count bottle, Rx Only, Mfg. by: Norwich… | Failed dissolution specifications | Alvogen, Inc | Terminated |
| Class II | August 21, 2019 | Nitrofurantoin Monohydrate/ Macrocrystalline Nitrofurantoin Monohydrate/Macrycrystals Capsules, 100 mg, 100-count bottle, Rx Only,… | Failed dissolution specifications | Alvogen, Inc | Terminated |
| Class II | August 21, 2019 | Hydrocortisone Cream With Aloe, Hydrocortisone 1% / Anti-Itch Cream with Aloe, 2 OZ (56… | CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified… | US Pharmaceuticals Inc. | Terminated |
| Class II | August 21, 2019 | Hydrocortisone Cream With Aloe, Hydrocortisone 1% / Anti-Itch Cream with Aloe, 1 OZ (28… | CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified… | US Pharmaceuticals Inc. | Terminated |
| Class II | August 21, 2019 | Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlorothiazide Tablets USP, 10 mg/12.5 mg, 100 tablet bottle, Rx… | Presence of Foreign Substance; Product complaints received related to brownish/blackish stains on the tablets and… | Lupin Pharmaceuticals Inc. | Terminated |
| Class III | August 21, 2019 | Clotrimazole and Betamethasone Dipropionate Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05%, 15 gram tubes, Rx only,… | Temperature Abuse: Complaints received of liquidy texture. | Glenmark Pharmaceuticals Inc., USA | Terminated |
| Class II | August 14, 2019 | Fungo Off Capsules, Distributed by Herbal Doctor Remedies, Alhambra, CA 91801-7081 USA,… | CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices. | Herbal Doctor Remedies | Terminated |
| Class II | August 14, 2019 | MIC B12 W/B6 (LIPOSTAT PLUS) 25/50/50/1/.175 MG/ML, 30 ML per vial, RXQ Compounding, 340… | Lack of Assurance of Sterility | RXQ Compounding LLC | Terminated |
| Class II | August 14, 2019 | Herpes-S, 500 mg Capsules, 90-count bottles, Herbal Doctor Remedies Alhambra, CA… | CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices. | Herbal Doctor Remedies | Terminated |
| Class II | August 14, 2019 | EDETATE DISODIUM 15% INJECTABLE, 100 ML per vial, RXQ Compounding, 340 West State Street,… | Lack of Assurance of Sterility | RXQ Compounding LLC | Terminated |
| Class II | August 14, 2019 | MANGANESE SULFATE MONOHYDRATE (PFV) 0.1MG/ML INJ, 10 ML per syringe, RXQ Compounding, 340… | Lack of Assurance of Sterility | RXQ Compounding LLC | Terminated |
| Class II | August 14, 2019 | NIACINAMIDE 100MG/ML, 10ML per vial, RXQ Compounding, 340 West State Street, Unit 9,… | Lack of Assurance of Sterility | RXQ Compounding LLC | Terminated |
| Class II | August 14, 2019 | PROCAINE HCL 20 MG/ML (MDV) INJECTABLE SOLUTION, 30 ML per vial. RXQ Compounding, 340… | Lack of Assurance of Sterility | RXQ Compounding LLC | Terminated |
| Class II | August 14, 2019 | Mometasone Furoate Mometasone Furoate Cream USP, 0.1%, packaged in a) 15gram tubes (NDC 68462-192-17) and b)… | GMP Deviations: Glenmark received complaints stating that mometasone fuorate cream was gritty. | Glenmark Pharmaceuticals Inc., USA | Terminated |
| Class II | August 14, 2019 | RXQ CAIN (PHENYLEP 1.5%/ LIDO 1% OPHTH SOL (PF), 1 ML PER VIAL, RXQ Compounding, 340 West… | Lack of Assurance of Sterility | RXQ Compounding LLC | Terminated |
| Class II | August 14, 2019 | Lump Off Capsules, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA,… | CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices. | Herbal Doctor Remedies | Terminated |
| Class II | August 14, 2019 | GLUTATHIONE 200MG/ML (PFV) INJECTION SOLN, 10 ML per vial, RXQ Compounding, 340 West… | Lack of Assurance of Sterility | RXQ Compounding LLC | Terminated |
| Class II | August 14, 2019 | VITAMIN B COMPLEX 100 (MDV), 30 ML per Vial, RXQ Compounding, 340 West State Street, Unit… | Lack of Assurance of Sterility | RXQ Compounding LLC | Terminated |
| Class II | August 14, 2019 | ZINC SULFATE 1MG/ML INJECTION SOLUTION (PFV), 10ML per VIAL, RXQ Compounding, 340 West… | Lack of Assurance of Sterility | RXQ Compounding LLC | Terminated |
| Class II | August 14, 2019 | TURBO DROPS (PHEN 0.625%/CYCLO 0.25%/TROP 0.25%/KETO 0.125%) OPHTH SOLN, 0.4 ML per… | Lack of Assurance of Sterility | RXQ Compounding LLC | Terminated |
| Class II | August 14, 2019 | METHYLCOBALAMIN (PFV) 10 MG/ML INJECTABLE, 10 ML per vial, RXQ Compounding, 340 West… | Lack of Assurance of Sterility | RXQ Compounding LLC | Terminated |
| Class II | August 14, 2019 | Lung Saver Capsules, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA,… | CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices. | Herbal Doctor Remedies | Terminated |
| Class II | August 14, 2019 | EPINEPHrine 1:1000 INJECTION SOLUTION (PF) Syringe, 1 ML per syringe, RXQ Compounding,… | Lack of Assurance of Sterility | RXQ Compounding LLC | Terminated |
| Class II | August 14, 2019 | VITAMIN B COMPLEX 100 (PFV), [2 or 30 ML] per Vial, RXQ Compounding, 340 West State… | Lack of Assurance of Sterility | RXQ Compounding LLC | Terminated |
| Class II | August 14, 2019 | Dragon Pain Balm, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA,… | CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices. | Herbal Doctor Remedies | Terminated |
| Class II | August 14, 2019 | Fungo Balm, 30 gram, Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808 | CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices. | Herbal Doctor Remedies | Terminated |
| Class II | August 14, 2019 | Deafness Off Capsules, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA,… | CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices. | Herbal Doctor Remedies | Terminated |
| Class II | August 14, 2019 | Migraine Off Capsules, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA,… | CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices. | Herbal Doctor Remedies | Terminated |
| Class II | August 14, 2019 | Appetrol Capsules, Distributed by Herbal Doctor Remedies, Alhambra, CA 91801-7081 USA,… | CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices. | Herbal Doctor Remedies | Terminated |
| Class II | August 14, 2019 | Glauco-Catar Capsules, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA,… | CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices. | Herbal Doctor Remedies | Terminated |
| Class II | August 14, 2019 | FENTANYL 2MCG/ML BUPIVACAINE 0.125% IN NACL 0.9% SRY C-II, 50ML per syringe (C-II) RXQ… | Lack of Assurance of Sterility | RXQ Compounding LLC | Terminated |
| Class II | August 14, 2019 | Detensin, 500 mg Capsules, 90-count bottles, Herbal Doctor Remedies Alhambra, CA… | CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices. | Herbal Doctor Remedies | Terminated |
| Class II | August 14, 2019 | Stomach Flu Capsules, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA,… | CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices. | Herbal Doctor Remedies | Terminated |
| Class II | August 14, 2019 | SODIUM BICARBONATE 8.4% (1 MEQ/ML) INJ SOLN (PFV), 50 ML PER VIAL, RXQ Compounding, 340… | Lack of Assurance of Sterility | RXQ Compounding LLC | Terminated |
| Class II | August 14, 2019 | Baby Saver Capsules, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA,… | CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices. | Herbal Doctor Remedies | Terminated |
| Class II | August 14, 2019 | ZINC SULFATE 1MG/ML INJECTION SOLUTION, 30ML per VIAL, RXQ Compounding, 340 West State… | Lack of Assurance of Sterility | RXQ Compounding LLC | Terminated |
| Class II | August 14, 2019 | CVS Health Children's Allergy Relief Liquid Medication Diphenhydramine HCl 12.5 mg/5 mL… | CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B.… | Unipharma, Llc. | Terminated |
| Class II | August 14, 2019 | KETAMINE 10 MG/ML INJ SOL SYR (C-III), [a) 2 ML NDC: 70731-0132-02; b) 5 ML NDC:… | Lack of Assurance of Sterility | RXQ Compounding LLC | Terminated |
| Class II | August 14, 2019 | fentaNYL 0.05MG/ML INJ SOL (PF), 55ML per syringe (C-II) RXQ Compounding, 340 West State… | Lack of Assurance of Sterility | RXQ Compounding LLC | Terminated |
| Class II | August 14, 2019 | Anemia Off, Distributed by Herbal Doctor Remedies, Alhambra, CA 91801-7081 USA, 1(800)… | CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices. | Herbal Doctor Remedies | Terminated |
| Class II | August 14, 2019 | Herpes-G Capsules, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA,… | CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices. | Herbal Doctor Remedies | Terminated |
| Class II | August 14, 2019 | HYDROGEN PEROXIDE 3% INJECTABLE PFV, 30 ML per vial, RXQ Compounding, 340 West State… | Lack of Assurance of Sterility | RXQ Compounding LLC | Terminated |
| Class II | August 14, 2019 | PROCAINE HCL 8% (PFV) INJECTABLE, 10ML PER VIAL, RXQ Compounding, 340 West State Street,… | Lack of Assurance of Sterility | RXQ Compounding LLC | Terminated |
| Class II | August 14, 2019 | Asma Aid Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800)… | CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices. | Herbal Doctor Remedies | Terminated |
| Class II | August 14, 2019 | PREDNISOLONE 1%, MOXIFLOXACIN 0.5% OPHTH SOL, 5ML per dropper bottle, RXQ Compounding,… | Lack of Assurance of Sterility | RXQ Compounding LLC | Terminated |