Drug and pharmaceutical recalls
17625 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2017-04-05FDA-DrugMylan Pharmaceuticals Inc.Class IIAtorvastatin Calcium Tablets, 20 mg*, packaged in a) 90-count bottles (NDC 0378-3951-09) and b) 500-count bottles (NDC 0378-3951-07); Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.
Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.
- 2017-04-05FDA-DrugMylan Pharmaceuticals Inc.Class IIAtorvastatin Calcium Tablets, 10 mg*, packaged in a) 90-count bottles (NDC 0378-3950-77); b) 90-count bottles (NDC 0378-3950-09); c) 500-count bottles (NDC 0378-3950-05); d) 500-count bottles (NDC 0378-3950-07), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.
Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.
- 2017-04-05FDA-DrugZydus Pharmaceuticals USA IncClass IIDivalproex Sodium Delayed Release Tablets, USP, 500 mg, a) 100 count (NDC 68382-033-01) and b) 500 count (NDC 68382-033-05) bottles, Rx only, manufactured by Cadila Healthcare Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals, Pennington, NJ
Failed Dissolution Specifications; 9 month long term stability
- 2017-04-05FDA-DrugClaris Lifesciences IncClass IIMetronidazole Injection, USP, 500 mg/100 mL, Rx only, Manufactured for: Claris Lifesciences Inc. North Brunswick NJ, 08902, By: Claris Injectable Ltd. Gujarat, India, NDC 36000-001-24
Lack of Assurance of Sterility: there is potential of a leak from the primary container which may result in a potential breach of sterility and contamination of the product.
- 2017-04-05FDA-DrugClaris Lifesciences IncClass IILevofloxacin Injection in 5% Dextrose, 750 mg in 150 mL 5% Dextrose, Rx only, Manufactured for: Claris Lifesciences Inc. North Brunswick NJ, 08902, By: Claris Injectable Ltd. Gujarat, India, NDC 36000-048-24
Lack of Assurance of Sterility: there is potential of a leak from the primary container which may result in a potential breach of sterility and contamination of the product.
- 2017-04-05FDA-DrugClaris Lifesciences IncClass IIFluconazole Injection, USP, 400 mg in 200 mL, Rx only, Manufactured for: Claris Lifesciences Inc. North Brunswick NJ, 08902, By: Claris Injectable Ltd. Gujarat, India, NDC 36000-003-06
Lack of Assurance of Sterility: there is potential of a leak from the primary container which may result in a potential breach of sterility and contamination of the product.
- 2017-04-05FDA-DrugClaris Lifesciences IncClass IICiprofloxacin in Dextrose (5%) Injection, USP, 400 mg in 200 mL 5% Dextrose, Rx only, Manufactured for: Claris Lifesciences Inc. North Brunswick NJ, 08902, By: Claris Injectable Ltd. Gujarat, India, NDC 36000-009-24
Lack of Assurance of Sterility: there is potential of a leak from the primary container which may result in a potential breach of sterility and contamination of the product.
- 2017-03-29FDA-DrugFougera Pharmaceuticals Inc.Class IIDesonide Ointment, 0.05%, NET WT 60 grams tubes, Rx only, E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc., Melville, New York 11747, NDC 0168-0309-60
Labeling: Label Mixup; Unit boxes labeled as Desonide Ointment 0.05% may contain tubes of Desonide Ointment labeled as Ketoconazole Cream
- 2017-03-29FDA-DrugSun Pharmaceutical Industries, Inc.Class IITestosterone Cypionate Injection , USP, 200 mg/mL, 1 mL vial , For Intramuscular Use Only, Rx Only, Distributed by Sun Pharma Ind. Inc., NJ 08512, Manufactured by Sun Pharma Ind. Ltd. India, NDC 62756-015-40
Presence of Particulate Matter
- 2017-03-29FDA-DrugAVKARE Inc.Class IIFamciclovir tablets, 500 mg, packaged in 30-count unit dose cartons, Rx only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478, NDC 50268-307-13
Failed impurities/ degradation specifications: Product was above specification for unknown impurities.
- 2017-03-29FDA-DrugPfizer IncClass IIIQuillivant XR (methylphenidate HCl) for extended-release oral suspension, 900 mg/180 mL (25mg/5mL), Rx Only, Distributed by: NextWave Pharmaceuticals, Inc. A subsidiary of Pfizer Inc, New York, NY 10017 Manufactured by: Tris Pharma, Inc., Monmouth Junction, NJ 08852 (NDC 24478-190-30).
Failed Dissolution Specifications: Dissolution at 8 hour was out of specification at 12 month at 25 degree Celsius.
- 2017-03-29FDA-DrugPfizer IncClass IIIQuillivant XR (methylphenidate HCl) for extended-release oral suspension, 750 mg/150 mL (25mg/5mL), Rx Only, Distributed by: NextWave Pharmaceuticals, Inc. A subsidiary of Pfizer Inc, New York, NY 10017 Manufactured by: Tris Pharma, Inc., Monmouth Junction, NJ 08852 (NDC 24478-205-25).
Failed Dissolution Specifications: Dissolution at 8 hour was out of specification at 12 month at 25 degree Celsius.
- 2017-03-29FDA-DrugPfizer IncClass IIIQuillivant XR (methylphenidate HCl) for extended-release oral suspension, 300 mg/60 mL (25mg/5mL), Rx Only, Distributed by: NextWave Pharmaceuticals, Inc. A subsidiary of Pfizer Inc, New York, NY 10017 Manufactured by: Tris Pharma, Inc., Monmouth Junction, NJ 08852 (NDC 24478-190-10).
Failed Dissolution Specifications: Dissolution at 8 hour was out of specification at 12 month at 25 degree Celsius.
- 2017-03-29FDA-DrugLegacy Pharmaceutical Packaging LLCClass IIATENOLOL Tablets, USP, 50 mg, 30-count bottle, Rx only, Distributed by: The Kroger Co., 1014 Vine Street, Cincinnati, OH 45202; Manufactured for: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534; Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO 63045; NDC 68645-493-54.
Presence of Foreign Tablets/Capsules: Customer complaint that a bottle of atenolol 50 mg Tablets USP contained a paroxetine 20 mg tablet.
- 2017-03-29FDA-DrugZydus Pharmaceuticals USA IncClass IIATENOLOL Tablets, USP, 50 mg, packaged in a) 100-count bottles (NDC 68382-023-01) and b) 1000-count bottles (NDC 68382-023-10), Rx only, Manufactured by: Cadila Healthcare Ltd., India; Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534.
Presence of Foreign Tablets/Capsules: Customer complaint that a bottle of atenolol 50 mg Tablets USP contained a paroxetine 20 mg tablet.
- 2017-03-29FDA-DrugBayer HealthCare Pharmaceuticals, Inc.Class IIIA+D Diaper Rash Cream with Dimethicone 1% and Zinc Oxide 10%, Packaged in a) 1.5 oz (42.5g) ( UPC 041100811288), b) 3 oz 85g (UPC 041100811301), c) 4 oz (113g) (UPC 041100811325), Distributed by: Bayer Healthcare LLC, Whippany, NJ 07981
Labeling: Incorrect/Undeclared Excipients: Firm is recalling A+D Diaper Rash Cream due to a labeling claim issue.
- 2017-03-22FDA-DrugPharmedium Services, LLCClass IIIBuffered Lidocaine, 1%, In Sodium Bicarbonate 8.4%, 1 mL Total Volume in a 3 mL syringe, Local anesthetic use, Rx only, PharMEDium, Product code 2K2466
Labeling; Label Mixup; outer packaging is incorrectly labeled as Buffered Lidocaine 1% instead of correctly as Buffered Lidocaine 0.9%
- 2017-03-22FDA-DrugSynergy RxClass IIKOJIC ACID 8%/AZELAIC ACID 15% CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
Lack of Assurance of Sterility: There are also CGMP Deviations.
- 2017-03-22FDA-DrugSynergy RxClass IIINTIMATE BLEACHING CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
Lack of Assurance of Sterility: There are also CGMP Deviations.
- 2017-03-22FDA-DrugSynergy RxClass IIGENTLE SUPREME BLEACHING CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
Lack of Assurance of Sterility: There are also CGMP Deviations.
- 2017-03-22FDA-DrugSynergy RxClass IICUSTOM LIGHTENING/BRIGHTENING CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
Lack of Assurance of Sterility: There are also CGMP Deviations.
- 2017-03-22FDA-DrugSynergy RxClass IISULFUR 5% CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
Lack of Assurance of Sterility: There are also CGMP Deviations.
- 2017-03-22FDA-DrugSynergy RxClass IISULFACETAMIDE 10%/HYDROCORTISONE 1% CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
Lack of Assurance of Sterility: There are also CGMP Deviations.
- 2017-03-22FDA-DrugSynergy RxClass IIHYDROCORTISONE 2.5% WITH ALOE VERA CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
Lack of Assurance of Sterility: There are also CGMP Deviations.
- 2017-03-22FDA-DrugSynergy RxClass IIMETRONIDAZOLE 1% GEL, METRONIDAZOLE 1%/ NIACINAMIDE 4%/ AZELAIC CREAM 10% CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
Lack of Assurance of Sterility: There are also CGMP Deviations.
- 2017-03-22FDA-DrugSynergy RxClass IIAZELAIC ACID 15% CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
Lack of Assurance of Sterility: There are also CGMP Deviations.
- 2017-03-22FDA-DrugSynergy RxClass IILIDOCAINE CREAM in all strengths including: 5%, 8%, 23%, 30%, LIDOCAINE / PRILOCAINE / MELYLEPHRINE 15% / 5% / 0.5% CREAM, LIDOCAINE / PRILOCAINE / MELYLEPHRINE 15% / 5% / 0.5% OINTMENT LIDOCAINE 23%/ TETRACAINE 7% CREAM, LIDOCAINE 23%/TETRACAINE 7% OINTMENT, LIDOCAINE 23%/TETRACAINE 7%/PRILOCAONE 2.5%, LIDOCAINE 24%/PRILOCAINE 26% OINTMENT, LIDOCAINE 30%/TETRACAINE 4% /PRILOCAINE 2%, LIDOCAINE 30%/PHENYLEPHRINE 0.25%, LIDOCAINE 30%/ TETRACAINE 10%, MELYLEPHRINE 4%, LIDOCAINE 30%/TETRACAIN
Lack of Assurance of Sterility: There are also CGMP Deviations.
- 2017-03-22FDA-DrugSynergy RxClass IIRETIN-A 0.05% CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
Lack of Assurance of Sterility: There are also CGMP Deviations.
- 2017-03-22FDA-DrugSynergy RxClass IIPURIFIED WATER, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
Lack of Assurance of Sterility: There are also CGMP Deviations.
- 2017-03-22FDA-DrugSynergy RxClass IIMELATONIN 1.5MG SPRAY, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
Lack of Assurance of Sterility: There are also CGMP Deviations.
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