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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
Most recent recall enforcement reports first.
Class Reported Product Reason Firm Status
Class II May 31, 2017 Meperidine HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of… Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. Advanced Pharma Inc. Terminated
Class II May 31, 2017 Lorazepam HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of… Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. Advanced Pharma Inc. Terminated
Class II May 31, 2017 Bumetadine all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston,… Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. Advanced Pharma Inc. Terminated
Class II May 31, 2017 Early TPN (Neonatal) all strengths, all dosage forms and all packaging, Rx Only, Avella… Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. Advanced Pharma Inc. Terminated
Class II May 31, 2017 Sodium Phosphate all strengths, all dosage forms and all packaging, Rx Only, Avella of… Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. Advanced Pharma Inc. Terminated
Class II May 31, 2017 Sufentanil Citrate all strengths, all dosage forms and all packaging, Rx Only, Avella of… Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. Advanced Pharma Inc. Terminated
Class II May 31, 2017 Heparin sodium all strengths, all dosage forms and all packaging, Rx Only, Avella of… Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. Advanced Pharma Inc. Terminated
Class II May 31, 2017 Alprazolam Extended-release Tablets, USP, 1 mg, 60-count bottle, Rx Only, Manufactured… Failed Dissolution Specifications Mylan Pharmaceuticals Inc. Terminated
Class II May 31, 2017 Betamethasone Sodium Phosphate & Betamethasone Acetate all strengths, all dosage forms… Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. Advanced Pharma Inc. Terminated
Class II May 31, 2017 Neostigmine Methylsulfate all strengths, all dosage forms and all packaging, Rx Only,… Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. Advanced Pharma Inc. Terminated
Class II May 31, 2017 RECK PeriCapsular injection all strengths, all dosage forms and all packaging, Rx Only,… Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. Advanced Pharma Inc. Terminated
Class I May 31, 2017 LaBri's Body Health Atomic, 60 capsules Marketed without an approved NDA/ANDA: Product contains undeclared Sibutramine. Envy Me Terminated
Class III May 31, 2017 Tarina Fe 1/20 (Norethindrone Acetate and Ethinyl Estradiol Tablets, USP and Ferrous… Chemical Contamination: out of specification results for impurities were found to be the result of contamination of… Mylan Pharmaceuticals Inc. Terminated
Class III May 31, 2017 Norethindrone Acetate and Ethinyl Estradiol Norethindrone Acetate and Ethinyl Estradiol Tablets, USP, 1 mg/0.02 mg, 1 blister pack… Chemical Contamination: out of specification results for impurities were found to be the result of contamination of… Mylan Pharmaceuticals Inc. Terminated
Class II May 31, 2017 SATO CLEAR (naphazoline hydrochloride) Redness Reliever Eye Drops, packaged in 0.5 FL OZ… Lack of Assurance of Sterility: Firm failed to establish an adequate system for monitoring environmental conditions in… Sato Pharmaceutical Inc. Terminated
Class II May 31, 2017 Optic Splash (naphazoline hydrochloride) Eye Drops, packaged in 0.5 FL OZ (15mL) bottles,… Lack of Assurance of Sterility: Firm failed to establish an adequate system for monitoring environmental conditions in… Sato Pharmaceutical Inc. Terminated
Class II May 31, 2017 VENTOLIN Ventolin HFA (albuterol sulfate) Inhalation, 90 mcg per actuation, 200 Metered… Defective Delivery System: Elevated number of units with out of specification results for leak rate GlaxoSmithKline, LLC Ongoing
Class III May 31, 2017 Children's Cetirizine Hydrochloride Chewable Tablets, 5 mg, 30-count bottle, Manufactured… Failed Tablet/Capsule Specifications: out of specification results for increased tablet hardness. Sun Pharmaceutical Industries, Inc. Terminated
Class I May 31, 2017 Dextrose Infant 25% DEXTROSE Injection, USP, 2.5 g (250 mg/mL), 10 mL Unit of Use Single-dose… Presence of Particulate Matter: human hair found within an internal sample syringe. Hospira Inc. Ongoing
Class II May 31, 2017 DORAMA-NEO (naphazoline hydrochloride) Eye wash, packaged in 0.5 FL OZ (15mL) bottles,… Lack of Assurance of Sterility: Firm failed to establish an adequate system for monitoring environmental conditions in… Sato Pharmaceutical Inc. Terminated
Class III May 31, 2017 Benzonatate Benzonatate capsules, 200 mg, 100-count bottle, Rx only, Manufactured by: Strides Shasun… Failed Stability Specifications: Out of Specification results obtained for preservative Methylparaben content. Strides Pharma INC Terminated
Class II May 24, 2017 PGE1 5ML MDV INJ, Injection, 40mcg/mL, Rx only, 5mL glass/Multiple Dose vial, Prepared by… Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance… Key Pharmacy and Compounding Center Terminated
Class II May 24, 2017 SODIUM BICARB 50ML MDV 8.4% (2 MOSMOL/ML) INJ, Injection, 8.40%, Rx only, 5mL… Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance… Key Pharmacy and Compounding Center Terminated
Class II May 24, 2017 PGE1 MDV 20MCG/ML INJ, Injection, 20mcg/mL, Rx only, packaged in a 5 mL, 10mL, and 15 mL… Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance… Key Pharmacy and Compounding Center Terminated
Class II May 24, 2017 PYRIDOXAL-5-PHOS 10ML MDV 100MG/ML INJ, Injection, 100mg/mL, Rx only, 10mL Glass/Multiple… Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance… Key Pharmacy and Compounding Center Terminated
Class II May 24, 2017 TRI MIX 10/30/0.5 *5ML* MDV MCG/MG/MG/ML INJ, Injection,10mcg/30mg/0.5mg/mL, Rx only, 5… Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance… Key Pharmacy and Compounding Center Terminated
Class II May 24, 2017 GLUTATHIONE INH *PV* 200MG/ML SOLN, Inhalation Solution, 200mg/mL, Rx only, 4mL… Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance… Key Pharmacy and Compounding Center Terminated
Class II May 24, 2017 GSH/NAC INH 2ML PV 60/100MG/ML SOLN, Inhalation Solution, 60mg/100mg/mL, Rx only, 5mL… Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance… Key Pharmacy and Compounding Center Terminated
Class II May 24, 2017 FERR GLUC MDV 60MG/ML INJ, Injection, 60mg/mL, Rx only, Packaged in 5mL and 10mL Glass… Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance… Key Pharmacy and Compounding Center Terminated
Class II May 24, 2017 TRI MIX 20/30/1 5ML MDV MCG/MG/MG/ML INJ, Injection, 20mcg/30mg/1mg/mL, Rx only, 5 mL… Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance… Key Pharmacy and Compounding Center Terminated
Class II May 24, 2017 ATROPINE SULFATE 0.01% OPHTH, Ophthalmic, 0.01%, Rx only, 15 mL Glass /Multiple Dose… Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance… Key Pharmacy and Compounding Center Terminated
Class II May 24, 2017 HYDROXO-B12 *1ML* SDV 1MG/ML INJ, Injection, 1mg/mL, Rx only, 1 mL Glass/Single Dose… Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance… Key Pharmacy and Compounding Center Terminated
Class II May 24, 2017 5-MTHF 10ML SDV (CALIF) 5MG/ML INJ, Injection 5mg/mL, Rx only, 10mL Glass /Single Dose… Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance… Key Pharmacy and Compounding Center Terminated
Class II May 24, 2017 TRI MIX 40/30/2 5ML MDV MCG/MG/MG/ML INJ, Injection, 40mcg/30mg/2mg/mL, Rx only, 5 mL… Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance… Key Pharmacy and Compounding Center Terminated
Class II May 24, 2017 DMPS ACID *5ML* SDV 50MG/ML INJ, Injection, 50mg/ml, Rx only, 5 mL glass/ Single Dose… Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance… Key Pharmacy and Compounding Center Terminated
Class II May 24, 2017 PAPAVERINE/PHENT 5ML MDV 30/1MG/ML INJ, Injection, 30mg/1mg/mL, Rx only, 5mL… Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance… Key Pharmacy and Compounding Center Terminated
Class II May 24, 2017 TRI MIX 20/30/0.5 5ML MDV MCG/MG/MG/ML INJ, Injection, 20mcg/30mg/0.5mg/mL, Rx only, 5 mL… Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance… Key Pharmacy and Compounding Center Terminated
Class II May 24, 2017 HYDROXO-B12 5ML PBF MDV (CALIF) 10MG/ML INJ, Injection, 10mg/mL, RX only, 5mL… Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance… Key Pharmacy and Compounding Center Terminated
Class II May 24, 2017 PROCAINE HCL SDV 1% INJ, Injection, 1%, Rx only, packaged in 5mL and 50 mL Glass/Single… Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance… Key Pharmacy and Compounding Center Terminated
Class II May 24, 2017 5-MTHF *10ML* MDV 5MG/ML INJ, Injection, 5mg/mL, Rx only, 10mL Glass/Multiple Dose vial,… Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance… Key Pharmacy and Compounding Center Terminated
Class II May 24, 2017 5-MTHF 10ML MDV (CALIF) 5MG/ML INJ, Injection, 5mg/mL, Rx only, 10mLGlass/Multiple Dose… Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance… Key Pharmacy and Compounding Center Terminated
Class II May 24, 2017 VITAMIN D3 IN OLIVE OIL SDV 100,000U/ML INJ, Injection, 100,000u/mL, Rx only, packaged in… Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance… Key Pharmacy and Compounding Center Terminated
Class II May 24, 2017 PGE1/PROCAINE 5ML MDV 20MCG/ML/0.1% INJ, Injection, 20mcg/ml 0.1%, Rx only, 5 mL… Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance… Key Pharmacy and Compounding Center Terminated
Class II May 24, 2017 TRI MIX 45.45/27.27/0.45 5ML MDV MCG/MG/MG/ML INJ, Injection, 45.45mcg/27.27mg/0.45mg/mL,… Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance… Key Pharmacy and Compounding Center Terminated
Class II May 24, 2017 IRON SPECIAL 5ML MDV 60/10MG/5MCG/ML INJ, Injection, 60mg/1mg/5mcg/mL, Rx only, 5mL Glass… Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance… Key Pharmacy and Compounding Center Terminated
Class II May 24, 2017 HYDROXO-B12 INH PF GV 5MG/ML SOLN, Inhalation Solution, 5mg/mL, Rx only, 5 mL… Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance… Key Pharmacy and Compounding Center Terminated
Class II May 24, 2017 TRI MIX 20/20/1 5ML MDV MCG/MG/MG/ML INJ, Injection, 20mcg/20mg/1mg/mL, Rx only, 5 mL… Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance… Key Pharmacy and Compounding Center Terminated
Class II May 24, 2017 TRI MIX 5.88/17.65/0.588 5ML MDV MCG/MG/MG/ML INJ, , Injection,… Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance… Key Pharmacy and Compounding Center Terminated
Class II May 24, 2017 HYDROXO-B12 1ML SDV 10MG/ML INJ, Injection, 10mg/mL, Rx only, 1 mL glass/ Single Dose… Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance… Key Pharmacy and Compounding Center Terminated
Class II May 24, 2017 VIT C/GSH 1.25%-1.25% OPHTH, Ophthalmic, 1.25%, Rx only, 15 mL Plastic/ Multiple Dose… Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance… Key Pharmacy and Compounding Center Terminated
Class II May 24, 2017 CO-Q-10 OIL 20ML MDV (CALIF) 25MG/ML INJ, Injection, 25mg/mL, Rx only, 20mL Glass… Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance… Key Pharmacy and Compounding Center Terminated
Class II May 24, 2017 METHYL-B12 5ML MDV (CALIF) 1MG/ML INJ, Injection, 1mg/mL, Rx only, 5 mL Glass/Multiple… Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance… Key Pharmacy and Compounding Center Terminated
Class II May 24, 2017 CHOL/IN/ME(L)/B6 10ML MDV 50/50/25/0.1MG/ML INJ, Injection, 50mg/50mg/25mg/0.1mg/mL, Rx… Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance… Key Pharmacy and Compounding Center Terminated
Class II May 24, 2017 HYDROXO-B12 5ML PBF MDV 1MG/ML INJ, Injection, 1mg/ml, Rx only, packaged in 5 mL Glass/… Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance… Key Pharmacy and Compounding Center Terminated
Class II May 24, 2017 TRI MIX 10/30/1 5ML MDV MCG/MG/MG/ML INJ, Injection, 10mcg/30mg/1mg/mL, Rx only, 5 mL… Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance… Key Pharmacy and Compounding Center Terminated
Class II May 24, 2017 QUAD MIX 1/30/0.5/0.1 5ML MDV MCG/MG/MG/MG/ML INJ, Injection, 1mcg/30mg/0.5mg/0.15mg/mL,… Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance… Key Pharmacy and Compounding Center Terminated
Class II May 24, 2017 VITAMIN D3 IN OLIVE OIL SDV 100,000U/ML INJ, Injection, 150,000u/mL, Rx only, packaged in… Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance… Key Pharmacy and Compounding Center Terminated
Class II May 24, 2017 SODIUM CARBOXYM-CELL PF 0.5% OPHTH, opthalmic, 0.50%, Rx only, 10mL Glass/Multiple Dose… Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance… Key Pharmacy and Compounding Center Terminated
Class II May 24, 2017 SODIUM CHLORIDE INH PF GV 0.9% SOLN, Inhalation Solution, 0.90%, Rx only, 5mL… Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance… Key Pharmacy and Compounding Center Terminated
Class II May 24, 2017 FOLIC ACID 1ML SDV 10MG/ML INJ, Injection, 10mg/mL, Rx only, 1 mL glass/Single Dose vial,… Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance… Key Pharmacy and Compounding Center Terminated
Class II May 24, 2017 MAGNESIUM SO4 10ML MDV 50% INJ, Injection, 50%, Rx only, 10 mL Glass/Multiple Dose vial,… Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance… Key Pharmacy and Compounding Center Terminated
Class II May 24, 2017 PROCAINE HCL 50ML MDV (CALIF) 1% INJ, Injection, 1%, Rx only, 50mL Glass/Multiple Dose… Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance… Key Pharmacy and Compounding Center Terminated
Class II May 24, 2017 HCG *10ML* MDV 500U/ML INJ, Injection, 500u/mL, Rx only, 10 mL Glass/Multiple Dose vial,… Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance… Key Pharmacy and Compounding Center Terminated
Class II May 24, 2017 TESTOST CYP SESAME OIL 5ML MDV 100MG/ML INJ, Injection, 100mg/mL, Rx only, 5 mL… Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance… Key Pharmacy and Compounding Center Terminated
Class II May 24, 2017 HYDROXO-B12 PBF MDV 10MG/ML INJ, Injection, 10mg/mL, Rx only, packaged in a 5 mL and 30… Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance… Key Pharmacy and Compounding Center Terminated
Class II May 24, 2017 GSH/NAC INH PV 150/50MG/ML SOLN, Inhalation Solution, 150mg/50mg/mL, Rx only, 4mL… Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance… Key Pharmacy and Compounding Center Terminated
Class II May 24, 2017 HYDROXO-B12 30ML PBF MDV (CALIF) 1MG/ML INJ, Injection, 1mg/mL, Rx only, 30 mL… Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance… Key Pharmacy and Compounding Center Terminated
Class II May 24, 2017 TRI MIX 10/15/1 5ML MDV MCG/MG/MG/ML INJ, Injection, 10mcg/15mg/1mg/mL, Rx only, 5 mL… Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance… Key Pharmacy and Compounding Center Terminated
Class II May 24, 2017 DMSO 6.25% OPHTH., 6.25%, Rx only, 15 mL plastic/Multiple Dose bottle, Prepared by Key… Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance… Key Pharmacy and Compounding Center Terminated
Class II May 24, 2017 CYANOCOBALAMIN 10ML MDV 1MG/ML INJ, Injection, 1mg/mL, Rx only, 10mL Glass/Multiple Dose… Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance… Key Pharmacy and Compounding Center Terminated
Class II May 24, 2017 TRI MIX 11.8/17.6/0.59 5ML MDV MCG/MG/MG/ML INJ, Injection, 11.8mcg/17.6mg/0.59mg/mL, Rx… Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance… Key Pharmacy and Compounding Center Terminated
Class II May 24, 2017 TESTOST AQ MDV 50MG/ML INJ, Injection, 50mg/mL, Rx only, packaged in 5mL and 10mL… Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance… Key Pharmacy and Compounding Center Terminated
Class II May 24, 2017 5-MTHF SDV 5MG/ML INJ, Injection, 5mg/mL, Rx only, packaged in 1 mL, 2 mL, 5 mL, and 10… Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance… Key Pharmacy and Compounding Center Terminated
Class II May 24, 2017 ALPHA LIPOIC ACID 25ML MDV 25MG/ML INJ, Injection, 25mg/mL, Rx only, 25 mL Glass/Multiple… Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance… Key Pharmacy and Compounding Center Terminated
Class II May 24, 2017 TRI MIX 6/18/0.6 5ML MDV MCG/MG/MG/ML INJ, Injection, 6mcg/18mg/0.6mg/mL, Rx only, 5 mL… Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance… Key Pharmacy and Compounding Center Terminated
Class II May 24, 2017 PGE1/CPZ 5ML MDV 20MCG/1MG/ML INJ, Injection, 20mcg/1mg/mL, Rx only, 5 mL Glass/Multiple… Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance… Key Pharmacy and Compounding Center Terminated
Class II May 24, 2017 FOLINIC ACID MDV INJ, Injection, 10 mg/mL, Rx only, packaged in 2mL and 10 mL… Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance… Key Pharmacy and Compounding Center Terminated
Class II May 24, 2017 FOLINIC ACID MDV (CALIF) 5MG/ML INJ, Injection, 5mg/mL, Rx only, packaged in 5 mL and10… Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance… Key Pharmacy and Compounding Center Terminated
Class II May 24, 2017 PROCAINE HCL SDV 2% INJ, Injection, 2%, Rx only, packaged in 10mL and 50 mL Glass/Single… Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance… Key Pharmacy and Compounding Center Terminated
Class II May 24, 2017 ATROPINE SULFATE 0.5% OPHTH, Ophthalmic 0.50%, Rx only, 15mlLGlass /Multiple Dose vial,… Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance… Key Pharmacy and Compounding Center Terminated
Class II May 24, 2017 PROGESTERONE SESAME OIL 10ML MDV 100MG/ML INJ, Injection, 100mg/mL, Rx only, 10mL Glass;… Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance… Key Pharmacy and Compounding Center Terminated
Class II May 24, 2017 HYDROXO-B12 10ML PBF MDV 5MG/ML INJ, 5mg/mL, Rx only, 10 mL Glass/ Multiple Dose vial,… Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance… Key Pharmacy and Compounding Center Terminated
Class II May 24, 2017 TRI MIX 10/15/2.5 5ML MDV MCG/MG/MG/ML INJ, Injection, 10mcg/15mg/2.5mg/mL, Rx only, 5 mL… Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance… Key Pharmacy and Compounding Center Terminated
Class II May 24, 2017 TRI MIX 5/30/0.5 5ML MDV MCG/MG/MG/ML INJ, Injection, 5mcg/30mg/0.5mg/mL, Rx only, 5 mL… Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance… Key Pharmacy and Compounding Center Terminated
Class II May 24, 2017 SOD PHENYLBUTYRATE SDV 30ML (CALIF or NEZ-CALIF) 200MG/ML INJ, Injection, 200mg/mL, Rx… Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance… Key Pharmacy and Compounding Center Terminated
Class II May 24, 2017 VITAMIN B COMPLEX 1ML SDV NA INJ, Injection, 100mg/2mg/2mg/2mg/100mg/mL, Rx only, 1mL… Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance… Key Pharmacy and Compounding Center Terminated
Class II May 24, 2017 PGE1/PROCAINE 5ML MDV 40MCG/ML/0.1% INJ, Injection, 40mcg/mL, 0.1%, Rx only, 5 mL… Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance… Key Pharmacy and Compounding Center Terminated
Class II May 24, 2017 PYRIDOXAL-5-PHOS 5ML MDV 50MG/ML INJ, 50mg/mL, Rx only, 5mL Glass/Multiple Dose vial,… Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance… Key Pharmacy and Compounding Center Terminated
Class II May 24, 2017 TRI MIX 16.7/4/0.27 5ML MDV MCG/MG/MG/ML INJ, Injection, 16.7mcg/4mg/0.27mg/ml, Rx only,… Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance… Key Pharmacy and Compounding Center Terminated
Class II May 24, 2017 PGE1/PAP 10/30 5ML MDV MCG/MG/ML INJ, Injection, 10mg/30mg/mL, Rx only, 5mL… Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance… Key Pharmacy and Compounding Center Terminated
Class II May 24, 2017 QUAD MIX 50/30/1/0.2 5ML MDV (CALIF) MCG/MG/MG/MG/ML INJ, Injection,… Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance… Key Pharmacy and Compounding Center Terminated
Class II May 24, 2017 METHYL-B12 *10ML* MDV 5MG/ML INJ, Injection, 5mg/mL, Rx only, 10 mL Glass/Multiple Dose… Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance… Key Pharmacy and Compounding Center Terminated
Class II May 24, 2017 TRI MIX 30/30/1 5ML MDV MCG/MG/MG/ML INJ, Injection, 30mcg/30mg/1mg/mL, Rx only, 5 mL… Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance… Key Pharmacy and Compounding Center Terminated
Class II May 24, 2017 TRI MIX 5.95/17.8572/0.6 5ML MDV MCG/MG/MG/ML INJ, Injection, 5.95mcg/17.85mg/0.6mg/mL,… Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance… Key Pharmacy and Compounding Center Terminated
Class II May 24, 2017 PROCAINE HCL *5ML* SDV SULFITE FREE 1% INJ, Injection, 1%, RXxonly, 5mL Glass/Single Dose… Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance… Key Pharmacy and Compounding Center Terminated
Class II May 24, 2017 TRI MIX 13/30/0.8 5ML MDV MCG/MG/MG/ML INJ, Injection, 13mcg/30mg/0.8mg/mL, RX only, 5 mL… Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance… Key Pharmacy and Compounding Center Terminated
Class II May 24, 2017 PAPAVERINE/PHENT 5ML MDV 30/0.5MG/ML INJ, Injection, 30/0.5mg/mL, Rx only, 5mL… Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance… Key Pharmacy and Compounding Center Terminated
Class II May 24, 2017 FERR GLUC/PROCAINE 10ML MDV 60/10MG/ML INJ, Injection, 60mg/10mg/mL, Rx only, 10 mL… Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance… Key Pharmacy and Compounding Center Terminated
Class II May 24, 2017 TRI MIX 40/30/4 5ML MDV MCG/MG/MG/ML INJ, Injection, 40mcg/30mg/4mg/mL, Rx only, 5 mL… Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance… Key Pharmacy and Compounding Center Terminated
Class II May 24, 2017 TRI MIX 20/30/2 5ML MDV MCG/MG/MG/1ML INJ, Injection, 20mcg/30mg/2mg/mL, Rx only, 5 mL… Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance… Key Pharmacy and Compounding Center Terminated
Class III May 24, 2017 Desoximetasone Ointment USP, 0.25%, 15 g tubes, Rx Only, Teligent Pharma, Inc. Buena. New… Superpotent Drug Teligent, Inc. Terminated
Class III May 24, 2017 Fluocinonide Fluocinonide Cream UPS, 0.05% (Emulsified Base), packaged in 60 g tube, Rx only, Mfd. by:… Cross contamination with other products: Certain lots of Fluocinonide Cream were found to be contaminated with a small… Taro Pharmaceuticals U.S.A., Inc. Terminated
Class II May 24, 2017 Milrinone Lactate in Dextrose Milrinone Lactate in 5% Dextrose Injection, 20 mg/100 mL, 100 mL Single-Dose Intravia… Lack of assurance of sterility: customer complaints received for the presence of leaks. Baxter Healthcare Corporation Terminated
Class II May 24, 2017 Fluconazole Fluconazole Injection, USP, 200 mg/100 mL (2mg/mL), 100 mL Single-Dose Intravia Container… Lack of assurance of sterility: customer complaints received for the presence of leaks. Baxter Healthcare Corporation Terminated
Class III May 17, 2017 Olanzapine Tablets, 7.5 mg, packaged in a) 30-count bottles (NDC 62756-553-83), b)… Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter… Sun Pharmaceutical Industries, Inc. Terminated
Class II May 17, 2017 Clozapine Tablets USP, 25 mg, 100-count bottle (NDC 0093-4359-01), 500- count bottle (NDC… Microbial Contamination of Non-Sterile Products Teva Pharmaceuticals USA Terminated
Class III May 17, 2017 Olanzapine Tablets, 2.5 mg, 1000-count bottles, Rx Only, Distributed by: Sun… Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter… Sun Pharmaceutical Industries, Inc. Terminated
Class III May 17, 2017 PrednisoLONE Oral Solution USP, 15 mg/5mL, alcohol content: 5%(v/v) 240 mL bottle, Rx… Failed Stability Specifications Teva Pharmaceuticals USA Terminated
Class III May 17, 2017 Olanzapine Tablets, 20 mg, packaged in a) 30-count bottles (NDC 62756-556-83), b)… Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter… Sun Pharmaceutical Industries, Inc. Terminated
Class III May 17, 2017 Olanzapine Tablets, 10 mg, packaged in a) 30-count bottles (NDC 62756-554-83), b)… Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter… Sun Pharmaceutical Industries, Inc. Terminated
Class III May 17, 2017 IC-Green (indocyanine green for injection, USP), 25 mg, packaged in a kit containing six… Product is being recalled due to low pH value. Akorn, Inc. Terminated
Class III May 17, 2017 Mozobil (plerixafor injection) 24mg/1.2mL (20mg/mL), For Single Use Only, Rx Only,… Labeling: Incorrect or Missing Package Insert Sanofi-Aventis U.S. LLC Terminated
Class II May 17, 2017 Buprenorphine Hydrochloride Buprenorphine HCI Injection, 0.3 mg/mL, 1 mL Single Dose Vial (NDC 42023-179-01),… Crystallization: due to the presence of white, crystalline particulates, adhered to the side and bottom of the glass… PAR Sterile Products LLC Terminated
Class II May 10, 2017 Rabeprazole Sodium Delayed Release Tablets, 20 mg, a) 30-count bottle (NDC… Failed Dissolution Specifications Amneal Pharmaceuticals LLC Terminated
Class III May 10, 2017 Zinc Oxide Paste 25%, 500 g, For Prescription Compounding, Fagron Inc.2400 Pilot Knob Rd,… Labeling: Error on Declared Strength: Error is due to an incorrect value in the Drug Facts Panel. The correct strength… Fagron, Inc Terminated
Class II May 10, 2017 Sulfamethoxazole and Trimethoprim Oral Suspension, USP 200 mg / 40 mg per 5 mL , Grape… Failed Dissolution Specifications Akorn Inc Terminated
Class III May 10, 2017 Allergy Relief Diphenhydramine HCl 25 mg, Antihistamine, Dye-Free, 24 Softgels,… Subpotent: This product is being recalled due to low out of specification assay results at the 9 month time point. P & L Development, LLC Terminated
Class I May 10, 2017 EPIPEN EpiPen Jr. 2-Pak (Epinephrine) Auto-Injectors 0.15 mg, Rx only, Manufactured for Mylan… Defective Delivery System; reports of the device failing to activate which could result in a patient not receiving… Meridian Medical Technologies a Pfizer Company Ongoing
Class I May 10, 2017 EPIPEN EpiPen 2-Pak (Epinephrine) Auto-Injectors 0.3 mg, Rx only, Manufactured for Mylan… Defective Delivery System; reports of the device failing to activate which could result in a patient not receiving… Meridian Medical Technologies a Pfizer Company Ongoing
Class III May 10, 2017 Aripiprazole Tablets, 2 mg, 30 count unit dose box, Rx only, Manufactured by Apotex Inc.,… Superpotent Drug; out of specification results for assay (manufacturer) The Harvard Drug Group Terminated
Class II May 10, 2017 Fluconazole Fluconazole Tablets, USP, 200 mg, 100-count Unit Dose carton, Rx only, Manufactured by… Failed Dissolution Specifications The Harvard Drug Group Terminated
Class II May 10, 2017 Fluconazole Fluconazole Tablets, USP, 100 mg, 100-count Unit Dose carton, Rx only, Manufactured by… Failed Dissolution Specifications The Harvard Drug Group Terminated
Class II May 3, 2017 Cyanocobalamin 1 mg/mL/ Methionine 25 mg/mL/ Inositol 50 mg/mL/ Choline 50 mg/mL, 30 mL… Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products… Isomeric Pharmacy Solution, LLC Terminated
Class II May 3, 2017 Testosterone Cypionate 200 mg/mL, Testosterone Propionate 20 mg/mL, 30 mL Multi-Dose Vial… Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products… Isomeric Pharmacy Solution, LLC Terminated
Class II May 3, 2017 Methylprednisolone Acetate 40 mg/mL, Lidocaine HCl 10 mg/mL, 10 mL Multi-Dose Vial For… Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products… Isomeric Pharmacy Solution, LLC Terminated
Class III May 3, 2017 Donepezil HCl tablets, 10mg, packaged in 10x10 blister packs per carton (100 Unit Dose)… Supotent: Out of Specification result for assay test during routine stability testing. Mckesson Packaging Services Terminated
Class III May 3, 2017 Isopto Carpine (pilocarpine hydrochloride opthalmic solution) 4%, packaged in 15 mL… Failed Impurities/Degradation Specifications. Novartis Pharmaceuticals Corp. Terminated
Class II May 3, 2017 Triamcinolone Acetonide 40 mg/mL, Lidocaine HCl 10 mg/mL , 10 mL Multi-Dose Vial For… Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products… Isomeric Pharmacy Solution, LLC Terminated
Class II May 3, 2017 hCG Body Shaper, Highly Purified Human Chorionic Gonadotrophin 5000 IU, Colloidal Silver… Marketed without an Approved NDA/ANDA; FDA analysis has found the product to be tainted with human chorionic… Gary Wood Terminated
Class II May 3, 2017 Phenylephrine 2.5%, Tropicamide 1%, 15 mL Multi-Dose Ophthalmic (spelled Opthalmic) Drops… Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products… Isomeric Pharmacy Solution, LLC Terminated
Class II May 3, 2017 Methylprednisolone Acetate 80 mg/mL, Lidocaine HCl 10 mg/mL, 10 mL Multi-Dose Vial For… Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products… Isomeric Pharmacy Solution, LLC Terminated
Class II May 3, 2017 Triamcinolone Diacetate 40 mg/mL, 10 mL Multi-Dose Vial For Injection, Rx Only, Isomeric… Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products… Isomeric Pharmacy Solution, LLC Terminated
Class III May 3, 2017 Pilocarpine Hydrochloride Pilocarpine Hydrochloride Ophthalmic Solution 4% , packaged in 15 mL bottles, Rx Only,… Failed Impurities/Degradation Specifications. Novartis Pharmaceuticals Corp. Terminated
Class III April 26, 2017 CLENZIderm M.D. Pore Therapy Salicylic Acid 2% Acne Treatment 5 fl. oz. (148 mL), Valeant… Discoloration. Valeant Pharmaceuticals North America LLC Terminated
Class III April 26, 2017 CLENZIderm M.D. Acne Treatment System, kit has 3 bottles a) Therapeutic Lotion (benzoyl… Discoloration. Valeant Pharmaceuticals North America LLC Terminated
Class III April 26, 2017 Diphenhydramine HCl 25 mg, Softgel Gelatin Capsule, 15,000-count bulk drums, aenova/Swiss… Subpotent InnovaGel Terminated
Class III April 26, 2017 Dye Free Allergy Softgel Gelatin Capsule, 15,000-count bulk drums, aenova/Swiss Caps USA,… Subpotent InnovaGel Terminated
Class II April 26, 2017 Nystatin and Triamcinolone Acetonide Nystatin and Triamcinolone Acetonide Cream, USP, 100,000 USP nystatin units and 1 mg… Failed Content Uniformity Specifications; out-of-specification (OOS) results 18-month stability Taro Pharmaceuticals U.S.A., Inc. Terminated
Class II April 19, 2017 Levonorgestrel Non-Micronized, USP, Bulk, Rx only, For Prescription Compounding,… cGMP Deviations; lack of quality assurance. Qinhuangdao Zizhu Pharmaceutical, Co. Terminated
Class II April 19, 2017 LATANOPROST OPHTHALMIC SOLUTION, 0.005%, 125 ug/2.5 mL, packaged in 2.5 mL bottle, Rx… Lack of assurance of sterility: product was found to be empty, under-filled, or leaking. Akorn, Inc. Terminated
Class II April 19, 2017 Estradiol Micronized Bulk, Rx only, For Prescription Compounding, Manufactured by… cGMP Deviations; lack of quality assurance. Qinhuangdao Zizhu Pharmaceutical, Co. Terminated
Class II April 19, 2017 Estriol Micronized, USP, Bulk, Rx only, For Prescription Compounding, Manufactured by… cGMP Deviations; lack of quality assurance. Qinhuangdao Zizhu Pharmaceutical, Co. Terminated
Class III April 19, 2017 Penicillin V Potassium Penicillin V Potassium Tablets, USP 500 mg (800,000 units) 1000 count bottles, Rx Only,… Presence of Foreign Tablet/Capsule; Amoxicillin 500 mg was found in bottles of Penicillin V potassium 500 mg Citron Pharma Llc Terminated
Class II April 19, 2017 Double Hyaluronic 1000, 'AN OUNCE OF GOLD' Volumizing Day Cream, Broad Spectrum SPF 30+,… Microbial Contamination of Non-Sterile Products: odor complaint of product due to microbial contamination. Signature Club A Ltd Ongoing
Class III April 19, 2017 BuPROPion Hydrochloride Extended-release Tablets, USP (SR), 100 mg, packaged in a)… Failed Impurities/Degradation Specifications: high out of specification results for one of the known degradation… Jubilant Cadista Pharmaceuticals, Inc. Terminated
Class III April 19, 2017 BuPROPion Hydrochloride Extended-release Tablets, USP (SR), 200 mg, packaged in a)… Failed Impurities/Degradation Specifications: high out of specification results for one of the known degradation… Jubilant Cadista Pharmaceuticals, Inc. Terminated
Class II April 19, 2017 ESTRIOL, USP (Micronized) Bulk, in a) 5 grams (NDC 38779-0732-03), b) 25 grams (NDC… cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection Medisca, Inc. Terminated
Class II April 19, 2017 Estradiol Non-Micronized, USP, Bulk, Rx only, For Prescription Compounding, Manufactured… cGMP Deviations; lack of quality assurance. Qinhuangdao Zizhu Pharmaceutical, Co. Terminated
Class III April 19, 2017 fluocinolone acetonide Fluocinolone Acetonide Topical Solution USP 0.01% For Topical Use Only, Not for… Chemical Contamination Novel Laboratories, Inc. Terminated
Class II April 19, 2017 Estrone Micronized, USP, Bulk, Rx only, For Prescription Compounding, Manufactured by… cGMP Deviations; lack of quality assurance. Qinhuangdao Zizhu Pharmaceutical, Co. Terminated
Class III April 19, 2017 BuPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg, packaged in a)… Failed Impurities/Degradation Specifications: high out of specification results for one of the known degradation… Jubilant Cadista Pharmaceuticals, Inc. Terminated
Class II April 19, 2017 Ethinyl Estradiol Micronized, USP, Bulk, Rx only, For Prescription Compounding,… cGMP Deviations; lack of quality assurance. Qinhuangdao Zizhu Pharmaceutical, Co. Terminated
Class II April 19, 2017 Testosterone Micronized, Bulk, Rx only, For Prescription Compounding, Manufactured by… cGMP Deviations; lack of quality assurance. Qinhuangdao Zizhu Pharmaceutical, Co. Terminated
Class II April 19, 2017 ESTRADIOL, USP (Hemihydrate)(Micronized), in a) 100 mg (NDC 38779-0869-07), b) 1 g (NDC… cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection Medisca, Inc. Terminated
Class III April 19, 2017 Doxercalciferol Capsules 0.5mcg, 50 count bottles, Rx, only, Manufactured by Cipla… Failed Tablet/Capsule Specifications; during an internal inspection, capsules were found with illegible print. West-Ward Columbus, Inc. Terminated
Class II April 19, 2017 ESTRADIOL, USP Bulk (Hemihydrate), in a) 25 g (NDC 38779-2261-04) and b) 100 g (NDC… cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection Medisca, Inc. Terminated
Class II April 19, 2017 ESTRONE, USP Bulk, in a) 100 mgs (NDC 38779-0891-05), b) 1 gram (NDC 38779-0891-06), c) 5… cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection Medisca, Inc. Terminated
Class II April 19, 2017 HYDRALAZINE HYDROCHLORIDE hydrALAZINE HYDROCHLORIDE INJECTION, USP, 20 mg/mL, 1 mL Single Dose Vial, packaged in 25… Temperature Abuse: Certain pieces of these lots distributed by McKesson Medical Surgical Inc. were inadvertently stored… Mckesson Medical Surgical Terminated
Class III April 19, 2017 Lumigan (bimatoprost ophthalmic solution) 0.01%, 7.5 mL bottle, Rx only, Allergan Irvine,… Failed Impurities/Degradation Specifications Allergan Sales, LLC Terminated
Class III April 12, 2017 Adalat CC (nifedipine) Extended Release Tablets 30 mg, 100-count bottles, Rx only,… Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib Alvogen, Inc Terminated
Class III April 12, 2017 Quinapril Quinapril Tablets USP 5 mg, 90 count bottles, Lupin Pharmaceuticals, Inc., Baltimore, MD… Failed Impurities/Degradation Specifications; Impurity A Lupin Pharmaceuticals Inc. Terminated
Class I April 12, 2017 Vancomycin HCl 1.5 gram added to 5% Dextrose 500 mL Total Approximate Volume 515 mL For… Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydrochloride 10gm vials… SCA Pharmaceuticals Terminated
Class III April 12, 2017 Fluphenazine Decanoate Injection, USP; 25 mg/mL, 5mL vials, Rx only, APP Pharmaceuticals,… Subpotent Drug Fresenius Kabi USA, LLC Terminated
Class I April 12, 2017 Vancomycin HCl 1 g added to 0.9% Sodium Chloride 250 mL Bag For IV Use Only, Rx Only, SCA… Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydrochloride 10gm vials… SCA Pharmaceuticals Terminated
Class III April 12, 2017 Adalat CC (nifedipine) Extended-Release Tablets, 90 mg, 100-count bottles, Rx Only,… Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib Alvogen, Inc Terminated
Class I April 12, 2017 ibuprofen lysine Ibuprofen Lysine Injection, 20 mg/2 mL (10 mg/mL), 2 mL Single-Dose Vial (NDC… Presence of Particulate Matter X-Gen Pharmaceuticals Inc. Terminated
Class III April 12, 2017 Adalat CC (nifedipine) Extended-Release Tablets, 90 mg, 100-count bottles, Rx Only,… Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib Alvogen, Inc Terminated
Class III April 12, 2017 Nifedipine Extended-Release Tablets, 90 mg, 100-count bottles, Rx Only, Manufactured for… Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib Alvogen, Inc Terminated
Class III April 12, 2017 Rivastigmine Tartrate RIVASTIGMINE Tartrate Capsules, USP, 1.5 mg, 60-count bottle, Rx Only, Mfd. By: Dr.… Cross-contamination with other products -Related Substances test for Rivastigmine Tartrate Capsules USP, 1.5 mg showed… Dr. Reddy's Laboratories, Inc. Terminated
Class I April 12, 2017 Vancomycin HCl 750 mg added to 5% Dextrose 250 mL For IV Use Only, Rx Only, SCA… Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydrochloride 10gm vials… SCA Pharmaceuticals Terminated
Class III April 12, 2017 Adalat CC (nifedipine) Extended-Release Tablets, 60 mg, 100-count bottles, Rx Only,… Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib Alvogen, Inc Terminated
Class I April 12, 2017 Vancomycin HCl 1.25 g added to 5% Dextrose 250 mL Bag For IV Use Only, Rx Only, SCA… Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydrochloride 10gm vials… SCA Pharmaceuticals Terminated
Class I April 12, 2017 Vancomycin HCl 1.5 g added to 0.9% Sodium Chloride 250 mL Bag For IV Use Only Rx Only,… Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydrochloride 10gm vials… SCA Pharmaceuticals Terminated
Class I April 12, 2017 XtraHRD Natural Male Enhancement Capsules, Herbal Dietary Supplement, 500 mg capsules, 2,… Marketed without an Approved NDA/ANDA: Product contains N-desmethyl tadalafil an analogue to tadalafil which is an… Organic Herbal Supply Terminated
Class I April 12, 2017 Vancomycin Hydrochloride for Injection, USP, 10 grams, Pharmacy Bulk Package - Not For… Presence of Particulate Matter: A hair was found stuck to the stopper of inside a single vial. The hair came in contact… Hospira Inc., A Pfizer Company Terminated
Class I April 12, 2017 Vancomycin HCl 750 mg added to 250 mL 0.9% Sodium Chloride For IV Use Only, Rx Only, SCA… Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydrochloride 10gm vials… SCA Pharmaceuticals Terminated
Class I April 12, 2017 Vancomycin HCl 1.25 g added to 0.9% Sodium Chloride 250 mL Bag For IV Use Only, Rx Only,… Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydrochloride 10gm vials… SCA Pharmaceuticals Terminated
Class III April 12, 2017 Nifedipine Extended-Release Tablets, 60 mg, 100-count bottles, Rx Only, Manufactured for… Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib Alvogen, Inc Terminated
Class III April 12, 2017 Adalat CC (nifedipine) Extended Release Tablets, 60 mg, 100- count bottles, Rx only… Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib Alvogen, Inc Terminated
Class III April 12, 2017 Nifedipine Extended-Release Tablets, 30 mg, 100-count bottles, Rx Only, Manufactured for… Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib Alvogen, Inc Terminated
Class III April 12, 2017 Adalat CC (nifedipine) Extended-Release Tablets, 30 mg, 100-count bottles, Rx Only,… Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib Alvogen, Inc Terminated
Class III April 12, 2017 Ciclopirox Olamine Ciclopirox Olamine Cream USP, 0.77%, packaged in a) 15 g tubes (NDC 0713-0638-15), b) 30… Labeling: Incorrect or Missing Package Insert: product lots packaged with an out-of-date insert. G & W Laboratories, Inc. Terminated
Class II April 12, 2017 Kalbitor (ecallantide), 10mg/mL, packaged in 3 vials per Carton, Rx Only, Dynax Corp.,… Presence of Particulate Matter: Glass Shire Terminated
Class II April 12, 2017 VENTOLIN Ventolin HFA (albuterol sulfate) Inhalation Aerosol, 90 mcg per actuation, 200 Metered… Defective Delivery System: Elevated number of units with out of specification results for leak rate. GlaxoSmithKline, LLC Ongoing
Class II April 12, 2017 Cotellic (cobimetinib) Tablets, 20 mg, 63 count bottle, Rx Only, Made in Switzerland.… Superpotent Drug: An oversized tablet was found in a bottle. Genentech Inc. Terminated
Class II April 5, 2017 ATORVASTATIN CALCIUM Atorvastatin Calcium Tablets, 10 mg*, 100-count Unit Dose Tablets (10 x 10) per carton,… Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of… Mylan Institutional, Inc. (d.b.a. UDL Laboratories) Terminated
Class II April 5, 2017 Fluconazole Injection, USP, 400 mg in 200 mL, Rx only, Manufactured for: Claris… Lack of Assurance of Sterility: there is potential of a leak from the primary container which may result in a potential… Claris Lifesciences Inc Terminated
Class II April 5, 2017 Metronidazole Injection, USP, 500 mg/100 mL, Rx only, Manufactured for: Claris… Lack of Assurance of Sterility: there is potential of a leak from the primary container which may result in a potential… Claris Lifesciences Inc Terminated
Class II April 5, 2017 Ciprofloxacin in Dextrose (5%) Injection, USP, 400 mg in 200 mL 5% Dextrose, Rx only,… Lack of Assurance of Sterility: there is potential of a leak from the primary container which may result in a potential… Claris Lifesciences Inc Terminated
Class II April 5, 2017 Sensodyne Repair & Protect Whitening, (stannous fluoride 0.45% (0.15% w/v fluoride ion)),… Presence of Foreign Substance; low concentration of an additional flavoring ingredient, Patchouli oil resulting in… GSK Consumer Healthcare Terminated
Class III April 5, 2017 Montelukast Sodium Montelukast sodium tablets, 10 mg, 30-count bottle, Rx Only, Manufactured for: Camber… Discoloration: the firm received a complaint of a sealed bottle in which tablets inside had blue spots and a blue… Hetero USA Inc Terminated
Class II April 5, 2017 Divalproex Sodium Delayed Release Tablets, USP, 500 mg, a) 100 count (NDC 68382-033-01)… Failed Dissolution Specifications; 9 month long term stability Zydus Pharmaceuticals USA Inc Terminated
Class II April 5, 2017 Levofloxacin Levofloxacin Injection in 5% Dextrose, 750 mg in 150 mL 5% Dextrose, Rx only,… Lack of Assurance of Sterility: there is potential of a leak from the primary container which may result in a potential… Claris Lifesciences Inc Terminated
Class II April 5, 2017 ATORVASTATIN CALCIUM Atorvastatin Calcium Tablets, 20 mg*, packaged in a) 90-count bottles (NDC 0378-3951-09)… Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of… Mylan Pharmaceuticals Inc. Terminated
Class II April 5, 2017 ATORVASTATIN CALCIUM Atorvastatin Calcium Tablets, 10 mg*, packaged in a) 90-count bottles (NDC 0378-3950-77);… Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of… Mylan Pharmaceuticals Inc. Terminated
Class II April 5, 2017 ATORVASTATIN CALCIUM Atorvastatin Calcium Tablets, 40 mg*, packaged in a) 90-count bottles (NDC 0378-3952-09)… Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of… Mylan Pharmaceuticals Inc. Terminated
Class II April 5, 2017 ATORVASTATIN CALCIUM Atorvastatin Calcium Tablets, 80 mg*, packaged in a) 90-count bottles (NDC 0378-3953-09)… Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of… Mylan Pharmaceuticals Inc. Terminated
Class II March 29, 2017 ATENOLOL Tablets, USP, 50 mg, 30-count bottle, Rx only, Distributed by: The Kroger Co.,… Presence of Foreign Tablets/Capsules: Customer complaint that a bottle of atenolol 50 mg Tablets USP contained a… Legacy Pharmaceutical Packaging LLC Terminated
Class III March 29, 2017 Quillivant XR (methylphenidate HCl) for extended-release oral suspension, 900 mg/180 mL… Failed Dissolution Specifications: Dissolution at 8 hour was out of specification at 12 month at 25 degree Celsius. Pfizer Inc Terminated
Class III March 29, 2017 A+D Diaper Rash Cream with Dimethicone 1% and Zinc Oxide 10%, Packaged in a) 1.5 oz… Labeling: Incorrect/Undeclared Excipients: Firm is recalling A+D Diaper Rash Cream due to a labeling claim issue. Bayer HealthCare Pharmaceuticals, Inc. Terminated
Class III March 29, 2017 Quillivant XR (methylphenidate HCl) for extended-release oral suspension, 750 mg/150 mL… Failed Dissolution Specifications: Dissolution at 8 hour was out of specification at 12 month at 25 degree Celsius. Pfizer Inc Terminated
Class III March 29, 2017 Quillivant XR (methylphenidate HCl) for extended-release oral suspension, 300 mg/60 mL… Failed Dissolution Specifications: Dissolution at 8 hour was out of specification at 12 month at 25 degree Celsius. Pfizer Inc Terminated
Class II March 29, 2017 Famciclovir tablets, 500 mg, packaged in 30-count unit dose cartons, Rx only,… Failed impurities/ degradation specifications: Product was above specification for unknown impurities. AVKARE Inc. Terminated
Class II March 29, 2017 Atenolol ATENOLOL Tablets, USP, 50 mg, packaged in a) 100-count bottles (NDC 68382-023-01) and b)… Presence of Foreign Tablets/Capsules: Customer complaint that a bottle of atenolol 50 mg Tablets USP contained a… Zydus Pharmaceuticals USA Inc Terminated
Class II March 29, 2017 Desonide Ointment, 0.05%, NET WT 60 grams tubes, Rx only, E. FOUGERA & CO. A division of… Labeling: Label Mixup; Unit boxes labeled as Desonide Ointment 0.05% may contain tubes of Desonide Ointment labeled as… Fougera Pharmaceuticals Inc. Terminated
Class II March 29, 2017 Testosterone Cypionate Testosterone Cypionate Injection , USP, 200 mg/mL, 1 mL vial , For Intramuscular Use… Presence of Particulate Matter Sun Pharmaceutical Industries, Inc. Terminated
Class II March 22, 2017 HYDROCORTISONE 2.5% WITH ALOE VERA CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A… Lack of Assurance of Sterility: There are also CGMP Deviations. Synergy Rx Terminated
Class II March 22, 2017 VITAMIN K OXIDE 5%, HQ 4%, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA… Lack of Assurance of Sterility: There are also CGMP Deviations. Synergy Rx Terminated
Class II March 22, 2017 LTP (Lidocaine 10%, Tetracaine 2%, Phenylephrine 0.5%), Rx only, Synergy RX, 4901 Morena… Lack of Assurance of Sterility: There are also CGMP Deviations. Synergy Rx Terminated
Class II March 22, 2017 FIRM AND FADE (Retinoic Acid 0.05%, Hydroquinone 6%, Kojic Acid 3%, Hydrocortisone 1%),… Lack of Assurance of Sterility: There are also CGMP Deviations. Synergy Rx Terminated
Class II March 22, 2017 MELATONIN 1.5MG SPRAY, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117… Lack of Assurance of Sterility: There are also CGMP Deviations. Synergy Rx Terminated
Class II March 22, 2017 TRETINOIN 0.02% IN OIL FREE CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San… Lack of Assurance of Sterility: There are also CGMP Deviations. Synergy Rx Terminated
Class II March 22, 2017 GENTLE BLEACHING CREAM (Retinoic Acid 0.025, Kojic Acid 3%,Hydrocortisone 1%), Rx only,… Lack of Assurance of Sterility: There are also CGMP Deviations. Synergy Rx Terminated
Class II March 22, 2017 CLINDAMYCIN 1%, AZELAIC ACID 10% CREAM, CLINDAMYCIN 1.2%/ TRETINOIN 0.05% GEL,… Lack of Assurance of Sterility: There are also CGMP Deviations. Synergy Rx Terminated
Class II March 22, 2017 TRI-BLEACHING CREAM (Retinoic Acid 0.05%, Hydroquinone 8%, Fluocinolone 0.01%), Rx only,… Lack of Assurance of Sterility: There are also CGMP Deviations. Synergy Rx Terminated
Class II March 22, 2017 CALMING CREAM (Hydrocortisone 2.5%, Aloe vera powder), Rx only, Synergy RX, 4901 Morena… Lack of Assurance of Sterility: There are also CGMP Deviations. Synergy Rx Terminated
Class II March 22, 2017 SULFACETAMIDE 10%/HYDROCORTISONE 1% CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A… Lack of Assurance of Sterility: There are also CGMP Deviations. Synergy Rx Terminated
Class II March 22, 2017 PURIFIED WATER, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855)… Lack of Assurance of Sterility: There are also CGMP Deviations. Synergy Rx Terminated
Class II March 22, 2017 GLYCOLIC ACID SOLUTION, all strengths including 10%, 20%, 30%, 50%, and 60%, Rx only,… Lack of Assurance of Sterility: There are also CGMP Deviations. Synergy Rx Terminated
Class II March 22, 2017 HI-LITE Cream (Retinoic Acid 0.05%, Hydroquinone 4%, Fluocinolone 0.01%), Rx only,… Lack of Assurance of Sterility: There are also CGMP Deviations. Synergy Rx Terminated
Class II March 22, 2017 BICARBONATE 10%, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855)… Lack of Assurance of Sterility: There are also CGMP Deviations. Synergy Rx Terminated
Class II March 22, 2017 REVERSE DML LOTION (Ketoconazole 2%, Metronidazole 2%, sulfacetamide sodium 10%), Rx… Lack of Assurance of Sterility: There are also CGMP Deviations. Synergy Rx Terminated
Class II March 22, 2017 CLOBETASOL 0.05% IN OLEA BASE, CLOBETASOL 0.05% IN OROBASE, CLOBETASOL 0.05% OINTMENT,… Lack of Assurance of Sterility: There are also CGMP Deviations. Synergy Rx Terminated
Class II March 22, 2017 HYDROQUINONE CREAM in all strengths including 4%, 5%,6%, 7%, 8%, HYDROQUINONE 5%/KOJIC… Lack of Assurance of Sterility: There are also CGMP Deviations. Synergy Rx Terminated
Class II March 22, 2017 ROSACEA CREAM ( Metronidazole 1%, Niacinamide 4%), Rx only, Synergy RX, 4901 Morena Blvd… Lack of Assurance of Sterility: There are also CGMP Deviations. Synergy Rx Terminated
Class II March 22, 2017 SULFUR 5% CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855)… Lack of Assurance of Sterility: There are also CGMP Deviations. Synergy Rx Terminated
Class II March 22, 2017 TRICHLOROACETIC ACID SOLUTION in all strengths including: 10%, 12%, 15 %, 20%, 35%, 70%,… Lack of Assurance of Sterility: There are also CGMP Deviations. Synergy Rx Terminated
Class II March 22, 2017 CANTHARADIN 0.7% SOLUTION and CANTHARIDAN / PODOPHYLLUM SOLUTION, CANTHARIDIN/PODOPHYLLUM… Lack of Assurance of Sterility: There are also CGMP Deviations. Synergy Rx Terminated
Class II March 22, 2017 BRIGHTENING CREAM (Retinoic acid 0.1%, Hydroquinone 4%, kojic acid 3%, hydrocortisone… Lack of Assurance of Sterility: There are also CGMP Deviations. Synergy Rx Terminated
Class II March 22, 2017 FLUOCINONIDE 0.05% SOLUTION, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA… Lack of Assurance of Sterility: There are also CGMP Deviations. Synergy Rx Terminated
Class II March 22, 2017 MINOXADIL all strength including 2%, 5% and MINOXIDIL / RETINOIC ACID 5% / 0.025, Synergy… Lack of Assurance of Sterility: There are also CGMP Deviations. Synergy Rx Terminated
Class II March 22, 2017 LP CREAM (Lidocaine 15%/Prilocaine 5%), Rx only, Synergy RX, 4901 Morena Blvd # 504-A San… Lack of Assurance of Sterility: There are also CGMP Deviations. Synergy Rx Terminated
Class II March 22, 2017 ULTRA LITE CREAM (Hydroquinone 8%), Rx only, Synergy RX, 4901 Morena Blvd # 504-A San… Lack of Assurance of Sterility: There are also CGMP Deviations. Synergy Rx Terminated
Class II March 22, 2017 UREA 40% Cream, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855)… Lack of Assurance of Sterility: There are also CGMP Deviations. Synergy Rx Terminated
Class II March 22, 2017 AZELAIC ACID 15% CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117… Lack of Assurance of Sterility: There are also CGMP Deviations. Synergy Rx Terminated
Class II March 22, 2017 DUO Cream (Retinoic Acid 0.05%, Hydroquinone 6%, Kojic Acid 3%, Hydrocortisone 0.1%), Rx… Lack of Assurance of Sterility: There are also CGMP Deviations. Synergy Rx Terminated
Class II March 22, 2017 MALEK'S MAGIC (retinoic acid 0.05%, hydroquinone 6%, kojic acid 3%, hydrocortisone 1%),… Lack of Assurance of Sterility: There are also CGMP Deviations. Synergy Rx Terminated
Class II March 22, 2017 RETIN-A 0.05% CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117… Lack of Assurance of Sterility: There are also CGMP Deviations. Synergy Rx Terminated
Class II March 22, 2017 HYDROQUINONE CREAM in all strengths including: 4%, 5%, 6%, 7%, 8%,10%, Rx only, Synergy… Lack of Assurance of Sterility: There are also CGMP Deviations. Synergy Rx Terminated
Class II March 22, 2017 TRI-BLEACHING CREAM HQ (retinoic Acid 0.05%, Hydroquinone 6%, Fluocinolone 0.01%), Rx… Lack of Assurance of Sterility: There are also CGMP Deviations. Synergy Rx Terminated
Class II March 22, 2017 TRI-BLEACHING CREAM (Retinoic Acid 0.1%, Hydroquinone 4%, Fluocinolone 0.01%), Rx only,… Lack of Assurance of Sterility: There are also CGMP Deviations. Synergy Rx Terminated
Class II March 22, 2017 HYDROQUINONE 28% SOLUTION, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA… Lack of Assurance of Sterility: There are also CGMP Deviations. Synergy Rx Terminated
Class III March 22, 2017 Buffered Lidocaine, 1%, In Sodium Bicarbonate 8.4%, 1 mL Total Volume in a 3 mL syringe,… Labeling; Label Mixup; outer packaging is incorrectly labeled as Buffered Lidocaine 1% instead of correctly as Buffered… Pharmedium Services, LLC Terminated
Class II March 22, 2017 GENERIC VI PEEL (Sal Acid 2%, TCA 7% Phenol 7%, Retinoic Acid 0.4%), Rx only, Synergy RX,… Lack of Assurance of Sterility: There are also CGMP Deviations. Synergy Rx Terminated
Class II March 22, 2017 DICLOFENAC 3% and 5% LIP BALM and DICLOFENAC 5% SPF 30 LIP BALM, Rx only, Synergy RX,… Lack of Assurance of Sterility: There are also CGMP Deviations. Synergy Rx Terminated
Class II March 22, 2017 METRONIDAZOLE 1% GEL, METRONIDAZOLE 1%/ NIACINAMIDE 4%/ AZELAIC CREAM 10% CREAM, Rx only,… Lack of Assurance of Sterility: There are also CGMP Deviations. Synergy Rx Terminated
Class II March 22, 2017 ERYTHROMYCIN 2% IN CERAVE CREAM, ERYTHROMYCIN 3% / RETINOIC ACID 0.05%, Rx only, Synergy… Lack of Assurance of Sterility: There are also CGMP Deviations. Synergy Rx Terminated
Class II March 22, 2017 LIDOCAINE CREAM in all strengths including: 5%, 8%, 23%, 30%, LIDOCAINE / PRILOCAINE /… Lack of Assurance of Sterility: There are also CGMP Deviations. Synergy Rx Terminated
Class II March 22, 2017 KOJIC ACID 8%/AZELAIC ACID 15% CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San… Lack of Assurance of Sterility: There are also CGMP Deviations. Synergy Rx Terminated
Class II March 22, 2017 GENTLE SUPREME BLEACHING CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego,… Lack of Assurance of Sterility: There are also CGMP Deviations. Synergy Rx Terminated