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 | November 25, 2015 | Triamcinolone/Lidocaine (40 mg/1%/mL), 10 mL Multidose Vial, For IM & Regional Injection,… | Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient… | US Compounding Inc | Terminated |
| Class II | November 25, 2015 | Glycopyrrolate USP ( 1 mg/5 mL), 5 mL Single Use syringe, For IM or IV Injection, Rx… | Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient… | US Compounding Inc | Terminated |
| Class II | November 25, 2015 | Voriconazole Solution (1%(10 mg/mL), 15 mL dropper bottle; For Topical Ophthalmic Use, Rx… | Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient… | US Compounding Inc | Terminated |
| Class II | November 25, 2015 | Sermorelin 1000 mcg/mL SUB-Q* Injection, packaged in a) 3 mL, b) 6mL, c) 7.5ml, d) 9 mL… | Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to… | Kalman Health & Wellness, Inc. dba Essential Wellness Pharma | Terminated |
| Class II | November 25, 2015 | DMPS Injectable, 50mg/mL, 5mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110,… | Lack of Assurance of Sterility | Downing Labs, LLC | Terminated |
| Class II | November 25, 2015 | Brompheniramine Maleate (10 mg/mL), 10 mL Multi-Dose Vial, Rx only, Compounded by US… | Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient… | US Compounding Inc | Terminated |
| Class II | November 25, 2015 | L-Glutathione Injection, 200mg/mL, 50mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd,… | Lack of Assurance of Sterility | Downing Labs, LLC | Terminated |
| Class II | November 25, 2015 | Methylcobalamin Injection Buffered 5mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001… | Lack of Assurance of Sterility | Downing Labs, LLC | Terminated |
| Class II | November 25, 2015 | Thiamine HCl Injection, 100mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd,… | Lack of Assurance of Sterility | Downing Labs, LLC | Terminated |
| Class II | November 25, 2015 | EDTA Disodium Injectable, 150mg/mL, 100mL vial, Rx only, Downing Labs, LLC 4001 McEwen… | Lack of Assurance of Sterility | Downing Labs, LLC | Terminated |
| Class II | November 25, 2015 | Calcium Gluconate (680mOsm/L) Injection 10%, 50mL vial, Rx only, Downing Labs, LLC 4001… | Lack of Assurance of Sterility | Downing Labs, LLC | Terminated |
| Class II | November 25, 2015 | Chromium Injectable, 200mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd,… | Lack of Assurance of Sterility | Downing Labs, LLC | Terminated |
| Class II | November 25, 2015 | Morphine PF (2 mg/2 mL), 2 mL Single Use Vial, For IV or IM Administration, Rx only,… | Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient… | US Compounding Inc | Terminated |
| Class II | November 25, 2015 | Testosterone CYP/ENAN/PROP Injection, 66.6 mg/66.6. mg/66.6 mg/mL, 5 mL vials, Rx only,… | Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to… | Kalman Health & Wellness, Inc. dba Essential Wellness Pharma | Terminated |
| Class II | November 25, 2015 | Dex Combo (Dexamethasone acetate 8mg/mL, dexamethasone sodium phosphate USP, 4 mg/mL),30… | Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient… | US Compounding Inc | Terminated |
| Class II | November 25, 2015 | MIC Injection, 30 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University,… | Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to… | Kalman Health & Wellness, Inc. dba Essential Wellness Pharma | Terminated |
| Class II | November 25, 2015 | B12 Injection 12.5/12.5MG, 3mL, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110,… | Lack of Assurance of Sterility | Downing Labs, LLC | Terminated |
| Class II | November 25, 2015 | Testosterone CYP/ENAN/PROP Injection in Cottonseed Oil, 66.6 mg/66.6. mg/66.6 mg/mL, 5 mL… | Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to… | Kalman Health & Wellness, Inc. dba Essential Wellness Pharma | Terminated |
| Class II | November 25, 2015 | Testosterone Cypionate Injection (Sesame Oil), 200mg/mL, 10mL vial, Rx only, Downing… | Lack of Assurance of Sterility | Downing Labs, LLC | Terminated |
| Class II | November 25, 2015 | MIC w/Methyl B-12 Preserved Injection, 25/50/50/1mg/mL, 50mL vial, Rx only, Downing Labs,… | Lack of Assurance of Sterility | Downing Labs, LLC | Terminated |
| Class II | November 25, 2015 | Methylcobalamin 20 mg/mL PF Injection, 0.05 mL prefilled syringes, Rx only, Essential… | Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to… | Kalman Health & Wellness, Inc. dba Essential Wellness Pharma | Terminated |
| Class II | November 25, 2015 | TRIMIX #2 (24 mg-0.8 mg-20 mcg /mL) Injection, 5 mL vials, Rx only, Essential Wellness… | Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to… | Kalman Health & Wellness, Inc. dba Essential Wellness Pharma | Terminated |
| Class II | November 25, 2015 | Phenylephrine PF Sterile Solution (2.5%), 3 mL Single Use Ophthalmic Dropper For Topical… | Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient… | US Compounding Inc | Terminated |
| Class II | November 25, 2015 | Taurine Injectable, 50mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite… | Lack of Assurance of Sterility | Downing Labs, LLC | Terminated |
| Class II | November 25, 2015 | 17-Alpha Hydroxyprogesterone 250 mg/mL in Sesame Oil Injection, 5 mL vials, Rx only,… | Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to… | Kalman Health & Wellness, Inc. dba Essential Wellness Pharma | Terminated |
| Class II | November 25, 2015 | Cyclosporin 0.1% Opth Solution, 10 mL dropper bottles, Rx only, Essential Wellness… | Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to… | Kalman Health & Wellness, Inc. dba Essential Wellness Pharma | Terminated |
| Class II | November 25, 2015 | Acetylcysteine 10% Oph Solution, packaged in a) 6 mL and b) 12 mL dropper bottles, Rx… | Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to… | Kalman Health & Wellness, Inc. dba Essential Wellness Pharma | Terminated |
| Class II | November 25, 2015 | L-Tyrosine Injectable, 25mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd,… | Lack of Assurance of Sterility | Downing Labs, LLC | Terminated |
| Class II | November 25, 2015 | HCG 3000 Units/mL Injection, 2 mL vial, Rx only, Essential Wellness PHARMACY, 4625 N.… | Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to… | Kalman Health & Wellness, Inc. dba Essential Wellness Pharma | Terminated |
| Class II | November 25, 2015 | TRIMIX SPECIAL (30 mg-1 mg-10 mcg/mL) Injection, 5 mL vials, Rx only, Essential Wellness… | Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to… | Kalman Health & Wellness, Inc. dba Essential Wellness Pharma | Terminated |
| Class II | November 25, 2015 | MIC-Combo, 30 mL Multi-Dose Vial, For Deep IM Injection Only, Rx only, Compounded by US… | Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient… | US Compounding Inc | Terminated |
| Class II | November 25, 2015 | Tropicamide 0.5%/ Phenylephrine 5%, 2 mL Dropper Bottle For Topical Ophthalmic Use, Rx… | Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient… | US Compounding Inc | Terminated |
| Class II | November 25, 2015 | L-Tryptophan Injectable, 30mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd,… | Lack of Assurance of Sterility | Downing Labs, LLC | Terminated |
| Class II | November 25, 2015 | Magnesium Sulfate 50% Injectable, 50mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd,… | Lack of Assurance of Sterility | Downing Labs, LLC | Terminated |
| Class II | November 25, 2015 | Procaine Injectables 20mg/mL and 2%, 50mL vial, Rx only, Downing Labs, LLC 4001 McEwen… | Lack of Assurance of Sterility | Downing Labs, LLC | Terminated |
| Class II | November 25, 2015 | Cyclo/PE/Trop PF (1%/2.5%/1%), 3 mL dropper bottle, For topical ophthalmic use, Rx only,… | Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient… | US Compounding Inc | Terminated |
| Class II | November 25, 2015 | L-Cysteine PF (50 mg/mL), 10 mL Single Dose Vial, For IV Use After Dilution, Rx only,… | Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient… | US Compounding Inc | Terminated |
| Class II | November 25, 2015 | Betamethasone SP, 2 mL (6 mg/mL),10 mL Multi-Dose Vial, For IM & Regional Injection, Rx… | Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient… | US Compounding Inc | Terminated |
| Class II | November 25, 2015 | TRIMIX #4 (27 mg-1.5 mg-50 mcg/mL) Injection, 5 mL vials, Rx only, Essential Wellness… | Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to… | Kalman Health & Wellness, Inc. dba Essential Wellness Pharma | Terminated |
| Class II | November 25, 2015 | LIPO B Injection, packaged in a) 2 mL, b) 12 mL, c) 15 mL, or d) 30 mL vials, Rx only,… | Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to… | Kalman Health & Wellness, Inc. dba Essential Wellness Pharma | Terminated |
| Class II | November 25, 2015 | Dapiprazole (Diluent+Powder) 0.5% in 5 mL vial, For topical ophthalmic use, Rx only,… | Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient… | US Compounding Inc | Terminated |
| Class II | November 25, 2015 | Hyaluronic Acid/Lidocaine (20 mg/1%/2 mL), 3 mL Single Use Syringe, For Intra-Articular… | Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient… | US Compounding Inc | Terminated |
| Class II | November 25, 2015 | Succinylcholine Chloride (200 mg/10 mL), 10 mL Single Use Syringe (20 mg/mL), For IV use,… | Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient… | US Compounding Inc | Terminated |
| Class II | November 25, 2015 | Progesterone 100 mg/mL Ethyl Oleate Injection, 10 mL vials, Rx only, Essential Wellness… | Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to… | Kalman Health & Wellness, Inc. dba Essential Wellness Pharma | Terminated |
| Class II | November 25, 2015 | Phenylephrine 10% PF Ophthalmic Solution, 3 mL dropper bottle, For Topical Ophthalmic… | Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient… | US Compounding Inc | Terminated |
| Class II | November 25, 2015 | HYDROCHLOROTHIAZIDE CAPSULES, USP, 12.5 mg, 3000 count bottles, Rx only, Manufactured… | Presence of Particulate Matter. | Vintage Pharmaceuticals LLC, DBA Qualitest Pharmaceuticals | Terminated |
| Class III | November 25, 2015 | RIFAMPIN FOR INJECTION USP, 600 mg*/vial, Rx Only. Mfd. for: Akorn, Inc., Lake Forest, IL… | Failed Impurity/Degradation Specifications: Out of Specifications result obtained for a known impurity. | Akorn, Inc. | Terminated |
| Class II | November 25, 2015 | Pilocarpine (1/16%) Ophthalmic, 15 mL dropper bottle, Rx only, Compounded by US… | Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient… | US Compounding Inc | Terminated |
| Class II | November 25, 2015 | Hydroxocobalamin Injection (Buffered) 1mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001… | Lack of Assurance of Sterility | Downing Labs, LLC | Terminated |
| Class II | November 25, 2015 | Hyaluronic Acid/Lidocaine PF (60 mg/2%), 3 mL Single Use Syringe, For Intra-Articular… | Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient… | US Compounding Inc | Terminated |
| Class II | November 25, 2015 | Triamcinolone diacetate USP PF (40 mg/mL), 2 mL Vial, For IM & Regional Injection, Rx… | Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient… | US Compounding Inc | Terminated |
| Class II | November 25, 2015 | Vitamin D3 Injectable, 10,000 U/mL, 10mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd,… | Lack of Assurance of Sterility | Downing Labs, LLC | Terminated |
| Class II | November 25, 2015 | Hyaluronic Acid/Lidocaine PF (20 mg/1%), 2 mL Single-Use Syringe , For Intra-Articular… | Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient… | US Compounding Inc | Terminated |
| Class II | November 25, 2015 | Cyanocobalamin Buffered Injectable 3mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001… | Lack of Assurance of Sterility | Downing Labs, LLC | Terminated |
| Class II | November 25, 2015 | Dex LA 8 (Dexamethasone acetate (8 mg/mL), 10 mL Multi-Dose Vial, For IM & Regional… | Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient… | US Compounding Inc | Terminated |
| Class III | November 25, 2015 | Hydrocortisone and Acetic Acid Otic Solution, USP, containing hydrocortisone (1%) and… | Defective Container: Product missing safety seal around the neck of the bottle. The product label indicates, "Tamper… | Akorn, Inc. | Terminated |
| Class II | November 25, 2015 | Pyridoxine Injection, 100 mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd,… | Lack of Assurance of Sterility | Downing Labs, LLC | Terminated |
| Class II | November 25, 2015 | HCG 1000 Units/mL SUB-Q Injection, packaged in a)1.5 mL, b) 2 mL, c) 2.4 mL, d) 4 mL, e)… | Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to… | Kalman Health & Wellness, Inc. dba Essential Wellness Pharma | Terminated |
| Class II | November 25, 2015 | TRIMIX #1 Injection, 4.2 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N.… | Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to… | Kalman Health & Wellness, Inc. dba Essential Wellness Pharma | Terminated |
| Class II | November 25, 2015 | Magnesium Chloride Hexahydrate Injection 200mg/mL, 50mL vial, Rx only, Downing Labs, LLC… | Lack of Assurance of Sterility | Downing Labs, LLC | Terminated |
| Class II | November 25, 2015 | Phenylephrine (1 mg/mL), 5 mL Multi-Dose Vial, For SC, IM, IV or penile injection, Rx… | Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient… | US Compounding Inc | Terminated |
| Class II | November 25, 2015 | Testosterone cypionate, USP (250 mg/mL), 10 mL Multi-Dose Vial, For Deep IM Injection… | Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient… | US Compounding Inc | Terminated |
| Class II | November 25, 2015 | Triamcinolone acetonide, USP (50 mg/mL), 10 mL Multi-Dose Vial, For IM & Regional… | Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient… | US Compounding Inc | Terminated |
| Class II | November 25, 2015 | Betamethasone Combo 10 mL (7 mg/mL), 10 mL Multi-Dose Vial,for IM & Regional Injection,… | Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient… | US Compounding Inc | Terminated |
| Class II | November 25, 2015 | Tri-Mix 30/1/10 (papaverine HCL USP 30 mg/ phentolamine mesylate USP 1 mg/ alprostadil… | Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient… | US Compounding Inc | Terminated |
| Class II | November 25, 2015 | 17-Alpha Hydroxyprogesterone 250 mg/mL in Castor Oil Injection, 5 mL vials, Rx only,… | Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to… | Kalman Health & Wellness, Inc. dba Essential Wellness Pharma | Terminated |
| Class II | November 25, 2015 | ePHEDrine Sulfate PF (50 mg/10 mL), 10 mL Single-Use Syringe, For IV or IM Use Rx only,… | Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient… | US Compounding Inc | Terminated |
| Class II | November 25, 2015 | Phosphatidylcholine/Deoxycholic Acid Injection (Preserved) 50 ML 10/4.75%;… | Lack of Assurance of Sterility | Downing Labs, LLC | Terminated |
| Class II | November 25, 2015 | Methylcobalamin 5000 mcg/mL Preservative Free Injection, packaged in a) 4 mL and b) 8 mL… | Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to… | Kalman Health & Wellness, Inc. dba Essential Wellness Pharma | Terminated |
| Class II | November 25, 2015 | MICML TRNDPPC Injection (Preserved) 10mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd,… | Lack of Assurance of Sterility | Downing Labs, LLC | Terminated |
| Class II | November 25, 2015 | ACETYLCYSTEINE 10% OPHTALMIC, 10 mL dropper bottle; For topical ophthalmic use, Rx.only,… | Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient… | US Compounding Inc | Terminated |
| Class II | November 25, 2015 | DMAE Dimethylaminoethanol Injection, 100mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001… | Lack of Assurance of Sterility | Downing Labs, LLC | Terminated |
| Class II | November 25, 2015 | Potassium Chloride Injection (20mEq/10mL), 2mEq/ML, 10mL vial, Rx only, Downing Labs, LLC… | Lack of Assurance of Sterility | Downing Labs, LLC | Terminated |
| Class II | November 25, 2015 | Piracetam Injection, 200mg/mL,10mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite… | Lack of Assurance of Sterility | Downing Labs, LLC | Terminated |
| Class II | November 25, 2015 | Methylcobalamin (12.5 mg/mL), 2.5 mL Multi-Dose Vial, For IM or SC Injection, Rx only,… | Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient… | US Compounding Inc | Terminated |
| Class II | November 25, 2015 | MethylPREDNISolone PF (80 mg/mL), 1 mL Single Use Vial, For IM & Regional Injection, Rx… | Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient… | US Compounding Inc | Terminated |
| Class III | November 25, 2015 | Meclizine Hydrochloride Tablets USP, 25 mg Tablets, Packaged in a) 100 Ct Bottles (NDC:… | Failed Impurities/Degradation Specifications: Out of specification for impurities. | Par Pharmaceutical Inc. | Terminated |
| Class II | November 25, 2015 | Riboflavin-5-Phosphate Injectable,10mg/mL, 10mL vial, Rx only, Downing Labs, LLC 4001… | Lack of Assurance of Sterility | Downing Labs, LLC | Terminated |
| Class II | November 25, 2015 | MedroxyPROGESTERone/Lidocaine (150 mg/mL/1%) 10 mL Multi-Dose Vial, For IM Injection… | Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient… | US Compounding Inc | Terminated |
| Class II | November 25, 2015 | Bi-Mix (Papaverine 30 mg/mL, Phentolamine 1 mg/mL), 5 mL Multi-Dose Vial, Rx only,… | Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient… | US Compounding Inc | Terminated |
| Class II | November 25, 2015 | Methylcobalamin Buffered Injectable, 5mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001… | Lack of Assurance of Sterility | Downing Labs, LLC | Terminated |
| Class II | November 25, 2015 | Testosterone Cypionate 200 mcg/mL in Sesame Oil Injection, packaged a) 5 mL and b) 100 mL… | Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to… | Kalman Health & Wellness, Inc. dba Essential Wellness Pharma | Terminated |
| Class II | November 25, 2015 | Co-Enzyme Q-10 Injectable, 20mg/mL, 10mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd,… | Lack of Assurance of Sterility | Downing Labs, LLC | Terminated |
| Class II | November 25, 2015 | Sermorelin 9 mg/10 mL SUB-Q* Injection, packaged in a) 3 mL, b) 5 mL, c) 6 mL, or d) 9 mL… | Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to… | Kalman Health & Wellness, Inc. dba Essential Wellness Pharma | Terminated |
| Class II | November 25, 2015 | TNPDR Injection Buffered, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite… | Lack of Assurance of Sterility | Downing Labs, LLC | Terminated |
| Class II | November 25, 2015 | Magnesium Sulfate Injectable, 14.28%, 7mL vial, Rx only, Downing Labs, LLC 4001 McEwen… | Lack of Assurance of Sterility | Downing Labs, LLC | Terminated |
| Class II | November 25, 2015 | Magnesium Sulfate Injection (4060mOsm/L), 50%, 50mL vial, Rx only, Downing Labs, LLC 4001… | Lack of Assurance of Sterility | Downing Labs, LLC | Terminated |
| Class II | November 25, 2015 | Lidocaine 1% PF(100 mg/10 mL),10 mL Single Use Syringe, For IV Injection, Rx only,… | Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient… | US Compounding Inc | Terminated |
| Class II | November 25, 2015 | Tropicamide 1%/Phenylephrine 2.5% (tropicamide USP 10 mg/ phenylephrine HCL USP 25 mg),… | Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient… | US Compounding Inc | Terminated |
| Class II | November 25, 2015 | Omnipaque 300 (600 mg/2 mL), 2 mL Single Use Vial (300 mg/mL), For IV or IT Injection, Rx… | Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient… | US Compounding Inc | Terminated |
| Class III | November 25, 2015 | Meclizine Hydrochloride Tablets, USP, 25 mg Tablets, Packaged in 10 x 10 Tablet Blister… | Failed Impurities/Degradation Specifications: Out of specification for impurities. | Mylan Institutional, Inc. (d.b.a. UDL Laboratories) | Terminated |
| Class II | November 25, 2015 | Fentanyl PF 50 mL (25 mcg/mL), 10 mL Single Use Syringe, For IV, IM or SC injection, Rx… | Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient… | US Compounding Inc | Terminated |
| Class II | November 25, 2015 | Dexamethasone 0.4% Opth Ointment, 3.5 g ointment tubes, Rx only, Essential Wellness… | Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to… | Kalman Health & Wellness, Inc. dba Essential Wellness Pharma | Terminated |
| Class II | November 25, 2015 | TNPRDC Injection, 6 mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas… | Lack of Assurance of Sterility | Downing Labs, LLC | Terminated |
| Class II | November 25, 2015 | Glycerin Opth Solution, 10 mL dropper bottles, Rx only, Essential Wellness PHARMACY, 4625… | Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to… | Kalman Health & Wellness, Inc. dba Essential Wellness Pharma | Terminated |
| Class II | November 25, 2015 | Vancomycin Ophthalmic PF 0.5 mL (5 mg/0.5 mL (10 mg/mL), 1 mL syringe, For Topical… | Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient… | US Compounding Inc | Terminated |
| Class II | November 25, 2015 | Methylcobalamin 25 mg/mL PF Injection, 0.5 mL prefilled syringes, Rx only, Essential… | Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to… | Kalman Health & Wellness, Inc. dba Essential Wellness Pharma | Terminated |
| Class II | November 25, 2015 | MIC Combo (Methionine 25 mg/mL, Inositol 50 mg/mL, Choline chloride 50 mg/mL,… | Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient… | US Compounding Inc | Terminated |
| Class II | November 25, 2015 | MethylPREDNISolone (100 mg/mL) 10 mL Multi-Dose Vial, For IM & Regional Injection, Rx… | Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient… | US Compounding Inc | Terminated |
| Class II | November 25, 2015 | L-Arginine Injection, 100mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd,… | Lack of Assurance of Sterility | Downing Labs, LLC | Terminated |
| Class II | November 25, 2015 | Neostigmine (5 mg/5 mL), 5 mL Single Use Syringe, For IM, SC or Slow IV Injection, Rx… | Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient… | US Compounding Inc | Terminated |
| Class II | November 25, 2015 | DMSO 99% Injection, 50mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110,… | Lack of Assurance of Sterility | Downing Labs, LLC | Terminated |
| Class II | November 25, 2015 | Prednisolone Sodium Phosphate PF Solution (1%) in 15 mL dropper bottle; For Topical… | Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient… | US Compounding Inc | Terminated |
| Class II | November 25, 2015 | HCG 10,000 Units/mL Injection, packaged in a) 1 mL, b) 1.2 mL, c) 1.6 mL, d) 2.0 mL, e)… | Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to… | Kalman Health & Wellness, Inc. dba Essential Wellness Pharma | Terminated |
| Class II | November 25, 2015 | Testosterone EO-Pro-Cyp 220 (220 mg/mL) 30 mL Multi-Dose Vial, For Deep IM Injection… | Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient… | US Compounding Inc | Terminated |
| Class II | November 25, 2015 | Dexamethasone Sodium Phosphate PF (10 mg/mL), 2 mL Single Use Vial, For IV or IM Use… | Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient… | US Compounding Inc | Terminated |
| Class II | November 25, 2015 | Betamethasone Combo PF 2 mL (6 mg/mL) 10 mL Multi-Dose Vial, For IM & Regional Injection,… | Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient… | US Compounding Inc | Terminated |
| Class II | November 25, 2015 | Vitamin D3 in Olive Oil (50,000 IU/mL) 30 mL vial, For IM Use only, Rx only, Compounded… | Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient… | US Compounding Inc | Terminated |
| Class II | November 25, 2015 | Methylcobalamin 30 mg/mL PF Injection, 0.1 mL prefilled syringes, Rx only, Essential… | Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to… | Kalman Health & Wellness, Inc. dba Essential Wellness Pharma | Terminated |
| Class II | November 25, 2015 | Progesterone 100 mg/mL IM* Injection in Sesame Oil, 10 mL vials, Rx only, Essential… | Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to… | Kalman Health & Wellness, Inc. dba Essential Wellness Pharma | Terminated |
| Class II | November 25, 2015 | Testosterone Cypionate 200 mcg/mL in Corn Oil Injection, 5 mL vials, Rx only, Essential… | Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to… | Kalman Health & Wellness, Inc. dba Essential Wellness Pharma | Terminated |
| Class II | November 25, 2015 | QUAD MIX (30 mg-1 mg-20 mcg-0.16 mg / mL) Injection, 5.2 mL vials, Rx only, Essential… | Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to… | Kalman Health & Wellness, Inc. dba Essential Wellness Pharma | Terminated |
| Class II | November 25, 2015 | Thiotic Acid Injection, 25mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd,… | Lack of Assurance of Sterility | Downing Labs, LLC | Terminated |
| Class III | November 25, 2015 | Meclizine Hydrochloride Tablets, USP, 12.5 mg Tablets, Packaged in a) 100 Ct Bottles… | Failed Impurities/Degradation Specifications: Out of specification for impurities. | Par Pharmaceutical Inc. | Terminated |
| Class II | November 25, 2015 | Testosterone Cypionate 50 mg/mL Injection, 1 mL vials, Rx only, Essential Wellness… | Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to… | Kalman Health & Wellness, Inc. dba Essential Wellness Pharma | Terminated |
| Class II | November 25, 2015 | BIMIX INJ 30 mg-1 mg/mL Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625… | Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to… | Kalman Health & Wellness, Inc. dba Essential Wellness Pharma | Terminated |
| Class II | November 25, 2015 | Choline chloride 50 mg/mL, Inositol 50 mg/mL Cyanocobalamin 1000 mcg/mL, 30 mL Multi-Dose… | Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient… | US Compounding Inc | Terminated |
| Class II | November 25, 2015 | Green Tea (EGCG) Injectable, 10mg/mL,10mL vial, Rx only, Downing Labs, LLC 4001 McEwen… | Lack of Assurance of Sterility | Downing Labs, LLC | Terminated |
| Class II | November 25, 2015 | Hyaluronidase PF (150 units/mL) in 1 mL Single-Use Vial, Not for IV Use, Rx only,… | Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient… | US Compounding Inc | Terminated |
| Class II | November 25, 2015 | Zinc Sulfate (1 mg/mL), 10 mL Single Dose Vial, For IV Use After Dilution, Rx only,… | Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient… | US Compounding Inc | Terminated |
| Class II | November 25, 2015 | LIPO-B Special Injection,12 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N.… | Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to… | Kalman Health & Wellness, Inc. dba Essential Wellness Pharma | Terminated |
| Class II | November 25, 2015 | L-Glutamine Injectable, 30mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd,… | Lack of Assurance of Sterility | Downing Labs, LLC | Terminated |
| Class II | November 25, 2015 | Methylcobalamin Buffered Injectable, 1mg/mL, packaged in a) 10mL vial, b) 30mL Rx only,… | Lack of Assurance of Sterility | Downing Labs, LLC | Terminated |
| Class II | November 25, 2015 | Cyclopent/PE/Tropic 2mL (1%/2.5%/0.25%), 2 mL dropper bottles; For topical ophthalmic… | Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient… | US Compounding Inc | Terminated |
| Class II | November 25, 2015 | Betamethasone SP PF (12 mg/mL), 2 mL Single Dose Vial, For IM & Regional Injection, Rx… | Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient… | US Compounding Inc | Terminated |
| Class II | November 25, 2015 | M.I.C Injection (Preserved), 25/50/25mg/mL, 50mL vial, Rx only, Downing Labs, LLC 4001… | Lack of Assurance of Sterility | Downing Labs, LLC | Terminated |
| Class II | November 25, 2015 | Methylprednisolone/Lidocaine (40 mg/mL/1%) 10 mL Multi-Dose Vial, For IM & Regional… | Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient… | US Compounding Inc | Terminated |
| Class II | November 18, 2015 | ESTRIOL 5 ESTRADIOL (Estradiol (E2) Trit (Yellow)) 0.95 ESTRONE (Estrone E1) Trit (Red))… | Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross… | the Compounder | Terminated |
| Class II | November 18, 2015 | TRIEST 70/20/10 ( Estriol USP / Estradiol USP (E2) / Estrone (E1) Triturate) [909]… | Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross… | the Compounder | Terminated |
| Class II | November 18, 2015 | BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : TESTO… | Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross… | the Compounder | Terminated |
| Class II | November 18, 2015 | BIEST TD 80/20 (Estradiol (E2) Trit (yellow) / Estriol USP Micronized (E3)): PROG… | Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross… | the Compounder | Terminated |
| Class II | November 18, 2015 | BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : PROG… | Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross… | the Compounder | Terminated |
| Class II | November 18, 2015 | PAPA/PGE1/PHENTO (15mg/5mcg/0.5mg/ml) Injection, 5 mL and 10 mL vials, Rx, B & B Health… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | Pacific Healthcare, Inc dba B&B Pharmacy | Terminated |
| Class II | November 18, 2015 | BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : PROG… | Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross… | the Compounder | Terminated |
| Class II | November 18, 2015 | BIEST TD 80/20 (Estriol USP Micronized (E3)/Estradiol (E2) Trit (Yellow))… | Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross… | the Compounder | Terminated |
| Class II | November 18, 2015 | BIEST TD 91/9 (Estriol USP Micronized (E3)/Estradiol (E2) Trit (Yellow)) : PROGESTERONE… | Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross… | the Compounder | Terminated |
| Class II | November 18, 2015 | Testosterone prop. 200 mg/ml Injection, 10 mL vial, Rx, B & B Health Mart Pharmacy,… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | Pacific Healthcare, Inc dba B&B Pharmacy | Terminated |
| Class II | November 18, 2015 | Testosterone Cypionate 250 mg/mL Injection, 10 mL vial, Rx, B & B Health Mart Pharmacy,… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | Pacific Healthcare, Inc dba B&B Pharmacy | Terminated |
| Class II | November 18, 2015 | BIEST TD 83/17 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) W/V… | Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross… | the Compounder | Terminated |
| Class II | November 18, 2015 | BIEST TD 50/50 (Estradiol USP Micronized (E2)/Estriol USP Micronized (E3)) W/V (weight… | Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross… | the Compounder | Terminated |
| Class II | November 18, 2015 | PAPA/PGE1/PHENTO (35mg/12mcg/1.5mg/ml), Injection, 10 mL vial, Rx, B & B Health Mart… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | Pacific Healthcare, Inc dba B&B Pharmacy | Terminated |
| Class II | November 18, 2015 | BIEST TD 80/20 (Estradiol USP Micronized (E2)/Estriol USP Micronized (E3)) W/V (weight… | Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross… | the Compounder | Terminated |
| Class II | November 18, 2015 | BIEST TD 89/11 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) W/V… | Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross… | the Compounder | Terminated |
| Class II | November 18, 2015 | ESTRIOL (E3) 4.0MG capsules, Rx only, The Compounder, 340 Marshall Avenue Unit 100,… | Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross… | the Compounder | Terminated |
| Class II | November 18, 2015 | BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : PROG… | Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross… | the Compounder | Terminated |
| Class II | November 18, 2015 | ESTRIOL (E3) W/V (weight/volume) PGF 0.1% (1.0MG/ML) Transdermal cream, is dispensed in 3… | Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross… | the Compounder | Terminated |
| Class II | November 18, 2015 | BIEST CP 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3)) 1.25 MG… | Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross… | the Compounder | Terminated |
| Class II | November 18, 2015 | TRIEST 80/10/10 (Estrone (E1) Trit / Estradiol (E2) Trit / Estriol USP (E3)) 1.875MG… | Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross… | the Compounder | Terminated |
| Class II | November 18, 2015 | BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3)) W/V… | Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross… | the Compounder | Terminated |
| Class I | November 18, 2015 | MIRACLE DIET 30 capsules, 30-count bottle, Manufactured Exclusively For: The One Minute… | Marketed Without An Approved NDA/ANDA: Miracle Diet 30 was found to contain undeclared phenolphthalein, a drug product… | The One Minute Miracle Inc | Ongoing |
| Class II | November 18, 2015 | PGE 20mcg/ml Injection, 10 mL vial, Rx, B & B Health Mart Pharmacy, Bellflower, CA | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | Pacific Healthcare, Inc dba B&B Pharmacy | Terminated |
| Class II | November 18, 2015 | PAPA/PGE1/PHENTO (22.5mg/8.33mcg/0.833mg/ml) Injection, 10 mL vial, Rx, B & B Health Mart… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | Pacific Healthcare, Inc dba B&B Pharmacy | Terminated |
| Class II | November 18, 2015 | BIEST CP 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3)) 2.5 MG… | Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross… | the Compounder | Terminated |
| Class II | November 18, 2015 | BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : PROG… | Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross… | the Compounder | Terminated |
| Class II | November 18, 2015 | ESTRIOL (E3) : ESTRADIOL (E2) (Estradiol (E2) Trit (Yellow)) : PROGEST (Progesterone USP)… | Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross… | the Compounder | Terminated |
| Class II | November 18, 2015 | BIEST 66/34: TESTOSTERONE : PROGESTERONE IN OLIVE OIL(Estradiol USP Micronized… | Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross… | the Compounder | Terminated |
| Class II | November 18, 2015 | PAPA/PHENTO (30mg/1mg/ml) Injection, 5 mL and 10 mL vials, Rx, B & B Health Mart… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | Pacific Healthcare, Inc dba B&B Pharmacy | Terminated |
| Class II | November 18, 2015 | BIEST CP 76/24: DHEA (Estriol USP Micronized (E3)/Estradiol (E2) Trit (Yellow) :… | Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross… | the Compounder | Terminated |
| Class II | November 18, 2015 | Nandrolone 200 mg/ml Injection, 10 mL and 20 mL vials, Rx, B & B Health Mart Pharmacy,… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | Pacific Healthcare, Inc dba B&B Pharmacy | Terminated |
| Class II | November 18, 2015 | BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : PROG… | Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross… | the Compounder | Terminated |
| Class II | November 18, 2015 | TRIEST 80/10/10 (E1/E2 Trit - Estrone (E1)/Estradiol (E2) / Estriol USP (E3)) (23) 5MG… | Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross… | the Compounder | Terminated |
| Class II | November 18, 2015 | BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : PROG… | Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross… | the Compounder | Terminated |
| Class II | November 18, 2015 | BIEST 80/20 : PROGEST : DHEA : TESTOST (Estriol USP Micronized (E3)/Estradiol (E2) Trit… | Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross… | the Compounder | Terminated |
| Class II | November 18, 2015 | BIEST TD 67/33 (Estradiol (E2) TRIT (YELLOW)/Estriol USP Micronized (E3)) W/V (weight… | Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross… | the Compounder | Terminated |
| Class II | November 18, 2015 | ESTRIOL (E3) : TESTO (Testosterone USP) WV (weight/volume) 0.5MG : 2MG/ML Transdermal… | Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross… | the Compounder | Terminated |
| Class II | November 18, 2015 | PAPA/PGE1/PHENTO (30mg/10mg/1mg/ml) Injection, 5 mL and 10 mL vials, Rx, B & B Health… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | Pacific Healthcare, Inc dba B&B Pharmacy | Terminated |
| Class II | November 18, 2015 | PAPA/PGE1/PHENTO (30mg/40mcg/1mg/ml) Injection, 10 mL vial, Rx, B & B Health Mart… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | Pacific Healthcare, Inc dba B&B Pharmacy | Terminated |
| Class II | November 18, 2015 | BIEST TD 50/50 (Estradiol USP Micronized (E2)/Estriol USP Micronized (E3)) W/V (weight… | Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross… | the Compounder | Terminated |
| Class II | November 18, 2015 | BIEST TD 80/20 (Estradiol USP Micronized (E2)/Estriol USP Micronized (E3)) W/V (weight… | Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross… | the Compounder | Terminated |
| Class II | November 18, 2015 | BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : PROG… | Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross… | the Compounder | Terminated |
| Class II | November 18, 2015 | BIEST TD 86/14 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) IN PLO GEL… | Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross… | the Compounder | Terminated |
| Class II | November 18, 2015 | Stanozolol 200 mg/ml Injection, 20 mL vial, Rx, B & B Health Mart Pharmacy, Bellflower, CA | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | Pacific Healthcare, Inc dba B&B Pharmacy | Terminated |
| Class II | November 18, 2015 | ESTRIOL (E3) : PROGESTERONE : DHEA (Dehydroepiandrosterone Micronized) W/V… | Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross… | the Compounder | Terminated |
| Class II | November 18, 2015 | ESTRIOL (E3) : ESTRADIOL (E2) (Estradiol (E2) Trit (Yellow)) : PROGEST (Progesterone USP)… | Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross… | the Compounder | Terminated |
| Class II | November 18, 2015 | ESTRIOL (E3) : PROGESTERONE W/V (weight/volume) 4.0 : 100 MG/ML Transdermal cream,… | Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross… | the Compounder | Terminated |
| Class II | November 18, 2015 | ESTRIOL (E3) : ESTRADIOL (E2) (Estradiol (E2) Trit (Yellow)) : TESTO (Testosterone USP)… | Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross… | the Compounder | Terminated |
| Class II | November 18, 2015 | ESTRIOL (E3) W/V (weight/volume) VERSABASE 3MG/ML Transdermal cream, dispensed in 5 mL… | Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross… | the Compounder | Terminated |
| Class II | November 18, 2015 | BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : PROG… | Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross… | the Compounder | Terminated |
| Class II | November 18, 2015 | PGE 30mcg/ml Injection, 10 mL vials, Rx, B & B Health Mart Pharmacy, Bellflower, CA | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | Pacific Healthcare, Inc dba B&B Pharmacy | Terminated |
| Class II | November 18, 2015 | BIEST TD 80/20 (estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3)) W/V… | Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross… | the Compounder | Terminated |
| Class II | November 18, 2015 | ESTRIOL (E3) W/V (weight/volume) VERSABASE [4714] 0.05% (0.5MG/ML) transdermal cream,… | Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross… | the Compounder | Terminated |
| Class II | November 18, 2015 | ESTRIOL (E3) 2.5MG suppositories, Rx only, The Compounder, 340 Marshall Avenue Unit 100,… | Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross… | the Compounder | Terminated |
| Class II | November 18, 2015 | BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : PROG… | Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross… | the Compounder | Terminated |
| Class II | November 18, 2015 | BIEST TD 80/20 (Estradiol USP Micronized (E2)/Estriol USP Micronized (E3)) W/V (weight… | Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross… | the Compounder | Terminated |
| Class II | November 18, 2015 | PAPA/PGE1/PHENTO (30mg/50mcg/0.5mg/ml), Injection, 10 mL vial, Rx, B & B Health Mart… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | Pacific Healthcare, Inc dba B&B Pharmacy | Terminated |
| Class II | November 18, 2015 | BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) VAN CR… | Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross… | the Compounder | Terminated |
| Class II | November 18, 2015 | BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : PROG… | Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross… | the Compounder | Terminated |
| Class II | November 18, 2015 | E2 (Estradiol (E2) Trit (Yellow) : E3 (Estriol USP Micronized (E3) : PROGEST… | Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross… | the Compounder | Terminated |
| Class II | November 18, 2015 | PGE 25mcg/ml, Injection, 10 mL vial, Rx, B & B Health Mart Pharmacy, Bellflower, CA | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | Pacific Healthcare, Inc dba B&B Pharmacy | Terminated |
| Class II | November 18, 2015 | PAPA/PHENTO (15mg/0.8333mg/ml) Injection, 5 mL vial, Rx, B & B Health Mart Pharmacy,… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | Pacific Healthcare, Inc dba B&B Pharmacy | Terminated |
| Class II | November 18, 2015 | PAPA+PGE1+PHENTO (30mg/20mcg/1mg/ml) Injection, 5 mL and 10 mL vials, Rx, B & B Health… | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and… | Pacific Healthcare, Inc dba B&B Pharmacy | Terminated |
| Class I | November 18, 2015 | MIRACLE ROCK 48 capsules, packaged in 2 x 2-count blisters, 4-count capsules per carton,… | Marketed Without An Approved NDA/ANDA: Miracle Rock 48 was found to contain undeclared thiosildenafil, an analogue of… | The One Minute Miracle Inc | Ongoing |
| Class III | November 18, 2015 | Duloxetine Duloxetine Delayed-release Capsules, USP, 60 mg, Rx Only, 1000 count bottle, Manufactured… | Presence of Foreign Tablets/Capsules: one foreign capsule identified as omeprazole 10 mg was found in the bottle | Breckenridge Pharmaceutical, Inc | Terminated |
| Class II | November 18, 2015 | Doxycycline Hyclate Tablets, USP, 100 mg, 500-count bottle, Rx only, Distributed by:… | Labeling: Wrong Bar Code | C. O. Truxton | Terminated |
| Class III | November 11, 2015 | RANITIDINE SYRUP (RANITIDINE ORAL SOLUTION, USP) 15 mg/mL (75 mg/5 mL), 473 mL (16 fl… | Failed Stability Specifications: Out of Specification results obtained for preservative butylparaben. | Vintage Pharmaceuticals LLC, DBA Qualitest Pharmaceuticals | Terminated |
| Class II | November 11, 2015 | Fenoglide (fenofibrate) tablets, 120 mg Tablets, 90 Ct Bottle, Rx Only. Distributed by:… | Failed Dissolution Specifications: Failed 24 month dissolution testing. | Valeant Pharmaceuticals North America LLC | Terminated |
| Class II | November 4, 2015 | ESTRADIOL, Pellet, 75 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy,… | Lack of Assurance of Sterility; all sterile human compounded drugs within expiry | JD & SN Inc., dba Moses Lake Professional Pharmacy | Terminated |
| Class II | November 4, 2015 | PAPAVERINE/PHENTOLAMINE/ATROPINE/PROSTAGLANDIN, Injectable Solution, 30 MG/2 MG/0.… | Lack of Assurance of Sterility; all sterile human compounded drugs within expiry | JD & SN Inc., dba Moses Lake Professional Pharmacy | Terminated |
| Class II | November 4, 2015 | VITAMIN D3 OIL, Injectable Solution, 50,000 UNITS/ML, syringe sizes: 10 mL and 30 mL, Rx… | Lack of Assurance of Sterility; all sterile human compounded drugs within expiry | JD & SN Inc., dba Moses Lake Professional Pharmacy | Terminated |
| Class II | November 4, 2015 | TRIMIX, injectable Solution, 30MG/1MG/10MCG, syringe sizes: 5 mL and 10mL, Rx only, JD &… | Lack of Assurance of Sterility; all sterile human compounded drugs within expiry | JD & SN Inc., dba Moses Lake Professional Pharmacy | Terminated |
| Class II | November 4, 2015 | TESTOSTERONE, Pellet, 100 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy,… | Lack of Assurance of Sterility; all sterile human compounded drugs within expiry | JD & SN Inc., dba Moses Lake Professional Pharmacy | Terminated |
| Class II | November 4, 2015 | CHORIONIC GONADOTROPIN, Injectable Solution,175 UNITS/1.5mg per syringe with… | Lack of Assurance of Sterility; all sterile human compounded drugs within expiry | JD & SN Inc., dba Moses Lake Professional Pharmacy | Terminated |
| Class II | November 4, 2015 | PAPAVERINE/PHENTOLAMINE/PROSTAGLANDIN, Injectable Solution, 9 MG/1 MG/10 MCG/ML, 10 mL… | Lack of Assurance of Sterility; all sterile human compounded drugs within expiry | JD & SN Inc., dba Moses Lake Professional Pharmacy | Terminated |
| Class II | November 4, 2015 | B1/B2/B3/B5/B12/LIDOCAINE/ISOLEUCINE/METHIONINE/CHOLINE/INOSITOL, Injectable Solution,… | Lack of Assurance of Sterility; all sterile human compounded drugs within expiry | JD & SN Inc., dba Moses Lake Professional Pharmacy | Terminated |
| Class II | November 4, 2015 | GLUTATHIONE MDV, Injectable Solution, 200 mg/mL, syringe sizes: 60 mL, 90 mL; 100 mL; and… | Lack of Assurance of Sterility; all sterile human compounded drugs within expiry | JD & SN Inc., dba Moses Lake Professional Pharmacy | Terminated |
| Class II | November 4, 2015 | TRI-MIX 20MCG+0.5MG+15MG/ML, 10 mL vial, Rx only, Park Compounding Pharmacy 280 N.… | Lack of Assurance of Sterility: all sterile compounded products within expiry | Chen Shwezin, Inc. dba Park Compounding Pharmacy | Terminated |
| Class II | November 4, 2015 | CHORIONIC GONADOTROPIN, Injectable Solution, 5000 UNITS/0.1 mL, vial sizes: 5 mL; 6 mL; 8… | Lack of Assurance of Sterility; all sterile human compounded drugs within expiry | JD & SN Inc., dba Moses Lake Professional Pharmacy | Terminated |
| Class II | November 4, 2015 | SODIUM TETRADECYL SULFATE, Injectable Solution, 3%, 2 mL syringe, Rx only, JD & SN Inc,… | Lack of Assurance of Sterility; all sterile human compounded drugs within expiry | JD & SN Inc., dba Moses Lake Professional Pharmacy | Terminated |
| Class II | November 4, 2015 | ESTRADIOL, Pellet, 20 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy,… | Lack of Assurance of Sterility; all sterile human compounded drugs within expiry | JD & SN Inc., dba Moses Lake Professional Pharmacy | Terminated |
| Class II | November 4, 2015 | TESTOSTERONE PROPRIONATE, Injectable Solution, 100 mg/mL, syringe size: 10mL, Rx only, JD… | Lack of Assurance of Sterility; all sterile human compounded drugs within expiry | JD & SN Inc., dba Moses Lake Professional Pharmacy | Terminated |
| Class II | November 4, 2015 | PROGESTERONE, Pellet, 200 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy,… | Lack of Assurance of Sterility; all sterile human compounded drugs within expiry | JD & SN Inc., dba Moses Lake Professional Pharmacy | Terminated |
| Class II | November 4, 2015 | DIHYDROERGOTAMINE MESYLATE, Injectable Solution, 1 MG/ML, 20 mL syringe, Rx only, JD & SN… | Lack of Assurance of Sterility; all sterile human compounded drugs within expiry | JD & SN Inc., dba Moses Lake Professional Pharmacy | Terminated |
| Class II | November 4, 2015 | TESTOSTERONE CYPIONATE FOR SUBQ INJECTION, Injectable Solution, 100 mg/mL, 10mL syringe,… | Lack of Assurance of Sterility; all sterile human compounded drugs within expiry | JD & SN Inc., dba Moses Lake Professional Pharmacy | Terminated |
| Class II | November 4, 2015 | TRI-MIX 10MCG+0.5MG+15MG/ML,5 mL vial, Rx only, Park Compounding Pharmacy 280 N. Westlake… | Lack of Assurance of Sterility: all sterile compounded products within expiry | Chen Shwezin, Inc. dba Park Compounding Pharmacy | Terminated |
| Class II | November 4, 2015 | METHYLCOBALAMIN MDV, Injectable Solution, 2 MG/ML, 10mL syringe; Rx only, JD & SN Inc,… | Lack of Assurance of Sterility; all sterile human compounded drugs within expiry | JD & SN Inc., dba Moses Lake Professional Pharmacy | Terminated |
| Class II | November 4, 2015 | CHORIONIC GONADOTROPIN/CYANOCOBALAMIN, Injectable Solution, 2000 unit/1mg/mL per syringe,… | Lack of Assurance of Sterility; all sterile human compounded drugs within expiry | JD & SN Inc., dba Moses Lake Professional Pharmacy | Terminated |
| Class II | November 4, 2015 | VITAMIN B-COMPLEX, Injectable Solution, Syringe size: 30 mL, Rx only, JD & SN Inc, DBA… | Lack of Assurance of Sterility; all sterile human compounded drugs within expiry | JD & SN Inc., dba Moses Lake Professional Pharmacy | Terminated |
| Class II | November 4, 2015 | PROGESTERONE, Pellet, 50mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy,… | Lack of Assurance of Sterility; all sterile human compounded drugs within expiry | JD & SN Inc., dba Moses Lake Professional Pharmacy | Terminated |
| Class II | November 4, 2015 | ESTRADIOL, Pellet, 12 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy,… | Lack of Assurance of Sterility; all sterile human compounded drugs within expiry | JD & SN Inc., dba Moses Lake Professional Pharmacy | Terminated |
| Class II | November 4, 2015 | SERMORELIN/GHRP-6/GHRP-2, Injectable Solution, 9/5.4/5.4MG/9ML, 9mL syringe, Rx only, JD… | Lack of Assurance of Sterility; all sterile human compounded drugs within expiry | JD & SN Inc., dba Moses Lake Professional Pharmacy | Terminated |
| Class II | November 4, 2015 | GLYCOPYRROLATE, Injectable Solution, 0.2 mg/mL, 300 mL syringe, Rx only, JD & SN Inc, DBA… | Lack of Assurance of Sterility; all sterile human compounded drugs within expiry | JD & SN Inc., dba Moses Lake Professional Pharmacy | Terminated |
| Class II | November 4, 2015 | PROGESTERONE, Pellet, 100 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy,… | Lack of Assurance of Sterility; all sterile human compounded drugs within expiry | JD & SN Inc., dba Moses Lake Professional Pharmacy | Terminated |
| Class II | November 4, 2015 | CHORIONIC GONADOTROPIN, Injectable Solution, 200 UNITS/0.1 ML, vial sizes: 4 mL; 5 mL; 6… | Lack of Assurance of Sterility; all sterile human compounded drugs within expiry | JD & SN Inc., dba Moses Lake Professional Pharmacy | Terminated |
| Class II | November 4, 2015 | ESTRADIOL, Pellet, 6 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555… | Lack of Assurance of Sterility; all sterile human compounded drugs within expiry | JD & SN Inc., dba Moses Lake Professional Pharmacy | Terminated |
| Class II | November 4, 2015 | HYDROXOCOBALAMIN (PRESERVATIVE FREE) UNIT DOSE SYRINGES, Injectable Solution, 3 mg/0.25… | Lack of Assurance of Sterility; all sterile human compounded drugs within expiry | JD & SN Inc., dba Moses Lake Professional Pharmacy | Terminated |
| Class II | November 4, 2015 | CAFFEINE + SODIUM BENZOATE 500MG/ML, 35 mL vial, Rx only, Park Compounding Pharmacy 280… | Lack of Assurance of Sterility: all sterile compounded products within expiry | Chen Shwezin, Inc. dba Park Compounding Pharmacy | Terminated |
| Class II | November 4, 2015 | PROSTAGLANDIN PGE-1 40MCG/ML, 10mL vial, Rx only, Park Compounding Pharmacy 280 N.… | Lack of Assurance of Sterility: all sterile compounded products within expiry | Chen Shwezin, Inc. dba Park Compounding Pharmacy | Terminated |
| Class II | November 4, 2015 | PAPAVERINE/PHENTOLAMINE/ATROPINE/PROSTAGLANDIN, Injectable Solution, 9 MG/1 MG/0.… | Lack of Assurance of Sterility; all sterile human compounded drugs within expiry | JD & SN Inc., dba Moses Lake Professional Pharmacy | Terminated |
| Class II | November 4, 2015 | METHYLCOBALAMIN MDV, Injectable Solution, 1 MG/ML, syringe sizes: 4 mL; 10 mL; 12 mL;… | Lack of Assurance of Sterility; all sterile human compounded drugs within expiry | JD & SN Inc., dba Moses Lake Professional Pharmacy | Terminated |
| Class II | November 4, 2015 | TRIMIX, injectable Solution, 20MG/1MG/20MCG/ML, 10mL syringe, Rx only, JD & SN Inc, DBA… | Lack of Assurance of Sterility; all sterile human compounded drugs within expiry | JD & SN Inc., dba Moses Lake Professional Pharmacy | Terminated |
| Class II | November 4, 2015 | TRIMIX, injectable Solution, 30MG/1MG/20MCG, 10mL syringe, Rx only, JD & SN Inc, DBA… | Lack of Assurance of Sterility; all sterile human compounded drugs within expiry | JD & SN Inc., dba Moses Lake Professional Pharmacy | Terminated |
| Class II | November 4, 2015 | MEDROXYPROGESTERONE ACETATE, injectable Solution,150MG/ML, 10mL syringe, Rx only, JD & SN… | Lack of Assurance of Sterility; all sterile human compounded drugs within expiry | JD & SN Inc., dba Moses Lake Professional Pharmacy | Terminated |
| Class II | November 4, 2015 | CHORIONIC GONADOTROPIN COMPOUNDED, Injectable Solution, 500 UNITS/0.5ML per syringe, Rx… | Lack of Assurance of Sterility; all sterile human compounded drugs within expiry | JD & SN Inc., dba Moses Lake Professional Pharmacy | Terminated |
| Class II | November 4, 2015 | EDETATE CALCIUM DISODIUM (SINGLE USE ONLY), Injectable Solution, 300 mg/mL, 10 mL… | Lack of Assurance of Sterility; all sterile human compounded drugs within expiry | JD & SN Inc., dba Moses Lake Professional Pharmacy | Terminated |
| Class II | November 4, 2015 | HYDROXOCOBALAMIN MULTIDOSE VIAL, Injectable Solution, 5 mg/mL, syringe sizes: 6 mL, 10… | Lack of Assurance of Sterility; all sterile human compounded drugs within expiry | JD & SN Inc., dba Moses Lake Professional Pharmacy | Terminated |
| Class II | November 4, 2015 | ESTRADIOL, Pellet, 30 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy,… | Lack of Assurance of Sterility; all sterile human compounded drugs within expiry | JD & SN Inc., dba Moses Lake Professional Pharmacy | Terminated |
| Class II | November 4, 2015 | ESTRADIOL, Pellet, 9 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555… | Lack of Assurance of Sterility; all sterile human compounded drugs within expiry | JD & SN Inc., dba Moses Lake Professional Pharmacy | Terminated |
| Class II | November 4, 2015 | CHORIONIC GONADOTROPIN COMPOUNDED, Injectable Solution, 200 UNITS/0.2ML per syringe, Rx… | Lack of Assurance of Sterility; all sterile human compounded drugs within expiry | JD & SN Inc., dba Moses Lake Professional Pharmacy | Terminated |
| Class II | November 4, 2015 | CHORIONIC GONADOTROPIN COMPOUNDED, Injectable Solution, 175 UNITS/0.175ML per syringe,… | Lack of Assurance of Sterility; all sterile human compounded drugs within expiry | JD & SN Inc., dba Moses Lake Professional Pharmacy | Terminated |
| Class II | November 4, 2015 | TRIMIX, injectable Solution, 15MG/.5MG/5MCG/ML, 10mL syringe, JD & SN Inc, DBA Moses Lake… | Lack of Assurance of Sterility; all sterile human compounded drugs within expiry | JD & SN Inc., dba Moses Lake Professional Pharmacy | Terminated |
| Class II | November 4, 2015 | TESTOSTERONE, Pellet, 50 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy,… | Lack of Assurance of Sterility; all sterile human compounded drugs within expiry | JD & SN Inc., dba Moses Lake Professional Pharmacy | Terminated |
| Class II | November 4, 2015 | B1/B2/B5/B12/LIDOCAINE/ISOLEUCINE/METHIONINE/CHOLINE/INOSITOL, Injectable Solution,… | Lack of Assurance of Sterility; all sterile human compounded drugs within expiry | JD & SN Inc., dba Moses Lake Professional Pharmacy | Terminated |
| Class II | November 4, 2015 | METHIONINE/CHOLINE/INOSITOL, injectable Solution, 25/50/50 MG/ML, 10 mL syringes, Rx… | Lack of Assurance of Sterility; all sterile human compounded drugs within expiry | JD & SN Inc., dba Moses Lake Professional Pharmacy | Terminated |
| Class II | November 4, 2015 | METHYLCOBALAMIN, Injectable Solution, 15 MG/ML, syringe sizes: 5 mL; 6 mL; 10 mL; 15 mL;… | Lack of Assurance of Sterility; all sterile human compounded drugs within expiry | JD & SN Inc., dba Moses Lake Professional Pharmacy | Terminated |
| Class II | November 4, 2015 | TESTOSTERONE/ANASTROZOLE, Pellet, 120/8 mg, Rx only, JD & SN Inc, DBA Moses Lake… | Lack of Assurance of Sterility; all sterile human compounded drugs within expiry | JD & SN Inc., dba Moses Lake Professional Pharmacy | Terminated |
| Class II | November 4, 2015 | ESTRADIOL, Pellet, 18 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy,… | Lack of Assurance of Sterility; all sterile human compounded drugs within expiry | JD & SN Inc., dba Moses Lake Professional Pharmacy | Terminated |
| Class II | November 4, 2015 | FOLIC ACID, Injectable Solution, 10 mg/mL, 30 mL syringe, Rx only, JD & SN Inc, DBA Moses… | Lack of Assurance of Sterility; all sterile human compounded drugs within expiry | JD & SN Inc., dba Moses Lake Professional Pharmacy | Terminated |
| Class II | November 4, 2015 | VITAMIN D3 OIL, Injectable Solution, 400,000 UNITS/ML, syringe size: 20 mL, Rx only, JD &… | Lack of Assurance of Sterility; all sterile human compounded drugs within expiry | JD & SN Inc., dba Moses Lake Professional Pharmacy | Terminated |
| Class II | November 4, 2015 | METHYLCOBALAMIN PRESERVATIVE FREE PREFILLED, Injectable Solution,1 mg/mL, Rx only, JD &… | Lack of Assurance of Sterility; all sterile human compounded drugs within expiry | JD & SN Inc., dba Moses Lake Professional Pharmacy | Terminated |
| Class II | November 4, 2015 | DMPS (DIMERCAPTO-PROPANESULFONIC NA (SINGLE USE ONLY), Injectable Solution, 500 mg/mL,… | Lack of Assurance of Sterility; all sterile human compounded drugs within expiry | JD & SN Inc., dba Moses Lake Professional Pharmacy | Terminated |