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FDA Recalls
›Drug Recalls

FDA Drug Recalls

Recalls of prescription drugs, over-the-counter medications, and compounded pharmaceuticals.

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 981–1000 of 1,000 recalls

Class IIITerminated

Atorvastatin Calcium 40 mg, 10 tablets per blister,100-count package, Rx Only Manufactured by Apotex Inc. Toronto, Ontario, Canada, Packaged by GSMS Inc., Camarillo, CA 93010, NDC # 60429-325-77

Golden State Medical Supply Inc.

Failed Impurities/Degradation Specifications

January 27, 2016 · DrugView details →

Class IIITerminated

Atorvastatin Calcium 10 mg, 10 tablets per blister,100-count package, Rx Only Manufactured by Apotex Inc. Toronto, Ontario, Canada, Packaged by GSMS Inc., Camarillo, CA 93010, NDC # 60429-323-77

Golden State Medical Supply Inc.

Failed Impurities/Degradation Specifications

January 27, 2016 · DrugView details →

Class IIITerminated

Atorvastatin Calcium 20 mg, 10 tablets per blister,100-count package, Rx Only Manufactured by Apotex Inc. Toronto, Ontario, Canada, Packaged by GSMS Inc., Camarillo, CA 93010, NDC # 60429-324-77

Golden State Medical Supply Inc.

Failed Impurities/Degradation Specifications

January 27, 2016 · DrugView details →

Class IIITerminated

Atorvastatin Calcium 80 mg, 10 tablets per blister,100-count package, Rx Only Manufactured by Apotex Inc. Toronto, Ontario, Canada, Packaged by GSMS Inc., Camarillo, CA 93010, NDC # 60429-326-77

Golden State Medical Supply Inc.

Failed Impurities/Degradation Specifications

January 27, 2016 · DrugView details →

Class IIITerminated

Duloxetine Delayed-Release Capsules, USP, 60 mg, 30-count bottles, Rx only, Manufactured by Apotex Inc, Toronto, Ontario M9L 1T9, Manufactured for Apotex Corp. Weston Florida 33326, NDC 60505-2997-3; UPC # 360505299737;

Apotex Scientific, Inc

Failed Dissolution Specification: Out of specification dissolution results when testing product stability.

January 26, 2016 · DrugView details →

Class IIITerminated

Candesartan Cilexetil Tablets, 16 mg, 30 Tablets (5 x 6) blister pack, Rx, Distributed by: American Health Packaging Columbus, Ohio 43217, NDC 68084-877-25(carton), NDC 68084-877-95(individual dose)

Amerisource Health Services

Failed Impurities/Degradation Specifications; 9 month stability (manufacturer)

January 26, 2016 · DrugView details →

Class IIITerminated

Duloxetine Delayed-Release Capsules, USP, 20 mg, 60-count bottles, Rx only, Manufactured by Apotex Inc, Toronto, Ontario M9L 1T9, Manufactured for Apotex Corp. Weston Florida 33326, NDC 60505-2995-6; UPC # 360505299560;

Apotex Scientific, Inc

Failed Dissolution Specification: Out of specification dissolution results when testing product stability.

January 26, 2016 · DrugView details →

Class IIITerminated

Duloxetine Delayed-Release Capsules, USP, 30 mg, 30-count bottles, Rx only, Manufactured by Apotex Inc, Toronto, Ontario M9L 1T9, Manufactured for Apotex Corp. Weston Florida 33326, NDC 60505-2996-3; UPC # 360505299638.

Apotex Scientific, Inc

Failed Dissolution Specification: Out of specification dissolution results when testing product stability.

January 26, 2016 · DrugView details →

Class IIITerminated

Cyclopentolate Hydrochloride Ophthalmic Solution USP, 1%, Packaged in a) 2 mL Bottles (NDC: 24208-735-01) and b) 15 mL Bottles (NDC: 24208-735-05), Rx Only. Bausch and Lomb Incorporated, Tampa, FL, 33637.

Bausch & Lomb, Inc.

Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert.

January 18, 2016 · DrugView details →

Class IIITerminated

Tropicamide Ophthalmic Solution USP, 0.5%, Packaged in 15 mL Bottles, Rx Only. Bausch and Lomb Incorporated, Tampa, FL, 33637. NDC: 24208-590-64.

Bausch & Lomb, Inc.

Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert.

January 18, 2016 · DrugView details →

Class IIITerminated

Tropicamide Ophthalmic Solution USP, 1%, Packaged in a) 2 mL Bottles (NDC: 24208-585-59) and b) 15 mL Bottles (NDC: 24208-585-64), Rx Only. Bausch and Lomb Incorporated, Tampa, FL, 33637.

Bausch & Lomb, Inc.

Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert.

January 18, 2016 · DrugView details →

Class IIITerminated

Virt-Nate Prenatal/Postnatal, Prescription Folate-Containing Dietary Supplement, Rx, 100 count bottles, Manufactured For: Virtus Pharmaceuticals, Tampa, FL

Virtus Pharmaceuticals, Llc

Tablets/Capsules Imprinted with Wrong ID; product debossed with an incorrect punch. Bottles could contain tablets debossed with V259 (debossing for PreTab) instead of the correct punch, V264 (debossing for Virt-Nate).

January 15, 2016 · DrugView details →

Class IIITerminated

risperiDONE ORALLY DISINTEGRATING TABLETS, 2 mg, 30 Ct Bottles, Rx Only. Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India. Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC: 68382-156-06.

Zydus Pharmaceuticals USA Inc

Failed Impurities/Degradation Specifications: Out of specification for a known degradant.

January 14, 2016 · DrugView details →

Class IIITerminated

NORepinephrine Bitartrate, 4 mg (16 mcg/mL) added to 250 mL 0.9% Sodium Chloride Injection USP, in 250 mL Viaflex Bag, Rx only, PharMEDium Services, LLC, Sugar Land, TX NDC 61553-134-61

Pharmedium Services, LLC

Subpotent Drug; confirmed results by FDA analysis after customer complaints of discoloration

December 31, 2015 · DrugView details →

Class IIITerminated

NORepinephrine Bitartrate, 8 mg (32 mcg/mL) added to 250 mL 0.9% Sodium Chloride Injection USP, in 250 mL Viaflex Bag Black, Rx only, PharMEDium Services, LLC, Sugar Land, TX NDC 61553-127-61

Pharmedium Services, LLC

Subpotent Drug; confirmed results by FDA analysis after customer complaints of discoloration

December 31, 2015 · DrugView details →

Class IIITerminated

Candesartan Cilexetil Tablets, 16 mg, a) 30 count (NDC 00781-5938-31) and b) 90 count (NDC 00781-5938-92) bottles, Rx Only, Manufactured by Mylan Laboratories Limited Hyderabad 500 034, India for Sandoz Inc. Princeton, NJ 08540

Sandoz Inc

Failed Impurities/Degradation Specifications; 9 month stability timepoint

December 31, 2015 · DrugView details →

Class IIITerminated

Life-Line DOCUSATE CALCIUM Sodium Free STOOL SOFTENER 240 mg each, 100 softgels per bottle. UPC 0-79854-95005-2 Manufactured and Distributed by: NATIONAL VITAMIN COMPANY Casa Grande, AZ 85122. NDC 54629-0640-01

National Vitamin Co Inc

Labeling: Label mix-up. Docusate Sodium 100mg Softgels were mislabeled as Docusate Calcium 240mg.

December 18, 2015 · DrugView details →

Class IIITerminated

VP-CH-PNV PRENATAL/POSTNATAL Prescription Folic Acid-Containing Dietary Supplement, 30-count Softgel bottles, Rx, Manufactured for Vitrus Pharmaceuticals, LLC, Tampa, FL 33619, NDC 69543-224-30, UPC 369543224305

Virtus Pharmaceuticals, Llc

Defective Delivery System: Product may contain leaking capsules.

December 17, 2015 · DrugView details →

Class IIITerminated

Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL (75 mg/5 mL), 16 fl oz Bottle, Rx only, Mfd For: Heritage Pharmaceuticals Inc., Eatontown, NJ 07724, NDC 23155-291-51

Bio-pharm, Inc.

Failed Impurities/Degradation Specifications: Product recalled due to elevated impurity result detected during routine stability testing.

December 17, 2015 · DrugView details →

Class IIITerminated

Lindane Lotion, USP 1%, For External use Only, Rx Only, 2 fl oz (60 mL) bottle, MGP, NDC 60432-833-60

Morton Grove Pharmaceuticals, Inc.

Super-Potent Drug: Out of Specification Assay test results were reported for stability samples.

December 15, 2015 · DrugView details →

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