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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 10901–10920 of 17,793 recalls

Class IITerminated

Nadolol Tablets, USP, 40mg, packaged in 1000-count bottle, Rx Only, Manufactured by Sandoz Inc., Princeton, NJ 08540, NDC 0781-1182-10

Sandoz Incorporated

Failed dissolution specification: recalled due to an out of specification dissolution result of 40% (Specification: NLT 80%)

December 22, 2016 · DrugView details →

Class IIITerminated

TEMAZEPAM CAPSULES USP, 7.5 mg, 100 count bottles, Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-5891-21

Vintage Pharmaceuticals LLC, DBA Qualitest Pharmaceuticals

Failed Stability Specifications

December 22, 2016 · DrugView details →

Class IITerminated

Furosemide Tablets USP, 20 mg, 1000 count bottles, Rx only, Roxane Laboratories, Inc., Columbus, Ohio 43216, NDC 0054-4297-31.

Roxane Laboratories, Inc.

Failed Tablet/Capsule Specifications: An unusually thick tablet was reported through a complaint.

December 22, 2016 · DrugView details →

Class IITerminated

Amoxicillin for Oral Suspension USP, 125 mg per 5 mL, packaged in a 100 mL bottle, Rx only, Manufactured for: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC 0093-4150-73

Teva Pharmaceuticals USA

Subpotency: due to a low, out of specification test result for assay during stability testing.

December 21, 2016 · DrugView details →

Class IITerminated

Temozolomide Capsules, 100 mg, packaged in a) 5-count bottles (NDC 0378-5262-98), b) 14-count bottles (NDC 0378-5262-14), Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 USA.

Mylan LLC.

Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resulting in loose powder in the bottle.

December 20, 2016 · DrugView details →

Class IITerminated

Temozolomide Capsules, 250 mg, 5-count bottles, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 USA, NDC 0378-5265-98.

Mylan LLC.

Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resulting in loose powder in the bottle.

December 20, 2016 · DrugView details →

Class IIITerminated

buPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg, a) 60 (NDC 47335-737-86), b) 100 (NDC 47335-737-88) and c) 500 (NDC 47335-737-13) count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India

Sun Pharmaceutical Industries, Inc.

Failed Dissolution Specifications; 18 month stability time point

December 20, 2016 · DrugView details →

Class IITerminated

Lisinopril tablets, 5 mg, 1000-count bottle, Rx only, Manufactured for Accord Healthcare, Inc., Durham, NC 27703, NDC 16729-376-17

Accord Healthcare, Inc.

Failed tablet/capsule specification: missing break line on the 5mg tablet.

December 20, 2016 · DrugView details →

Class IIITerminated

buPROPion Hydrochloride Extended-release Tablets, USP (SR), 200 mg, 60 count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India NDC 47335-0738-86

Sun Pharmaceutical Industries, Inc.

Failed Dissolution Specifications; 18 month stability time point

December 20, 2016 · DrugView details →

Class IITerminated

Temozolomide Capsules, 180 mg, packaged in a) 5-count bottles (NDC 0378-5264-98), b) 14-count bottles (NDC 0378-5264-14), Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 USA.

Mylan LLC.

Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resulting in loose powder in the bottle.

December 20, 2016 · DrugView details →

Class IITerminated

Temozolomide Capsules, 140 mg, packaged in a) 5-count bottles (NDC 0378-5263-98), b) 14-count bottles (NDC 0378-5263-14), Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 USA.

Mylan LLC.

Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resulting in loose powder in the bottle.

December 20, 2016 · DrugView details →

Class IIITerminated

Aripiprazole Tablets, 2 mg, 30-count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9; Manufactured for: Apotex Corp., Weston, Florida 33326, NDC 60505-3075-3.

Apotex Inc.

Superpotent Drug: Product may not meet specifications throughout shelf life.

December 19, 2016 · DrugView details →

Class IIITerminated

Pantoprazole Sodium for Injection, 40mg per vial, Single-dose vial, Rx only, Mfd. in India for: Auromedics Pharma LLC 6 Wheeling Road, Dayton, NJ 08810, NDC 55150-202-00

Aurobindo Pharma USA Inc

Discoloration: Some vials were found to contain powder with a yellowish-brownish appearance.

December 16, 2016 · DrugView details →

Class IITerminated

MIDAZOLAM INJECTION, USP, *25 mg/5 mL, (5 mg/ mL), 5 mL vials, 10 Vials per carton, Rx only, APP Pharmaceuticals, LLC Schaumburg, IL 60173 --- NDC 63323-412-05

Fresenius Kabi USA, LLC

Failed Impurities/Degradation Specifications

December 16, 2016 · DrugView details →

Class IITerminated

AMGEN Kyprolis (carfilzomib) for injection, 30 mg per vial, Discard unused portion, For Intravenous Administration Only, Rx Only, Manufactured for: Onyx Pharmaceuticals, Inc., Thousand Oaks, CA 91320-1799, U.S.A., NDC 76075-102-01

Amgen, Inc.

Lack of Assurance of Sterility: Potential cracks in glass vials

December 15, 2016 · DrugView details →

Class IITerminated

Gentell Hydrogel Wound Dressing REGULAR, 4 oz. tube, Manufactured by: Gentell, 2701 Bristol, PA 19007, NDC 61554-111-04

Gentell, Inc

CGMP Deviations

December 15, 2016 · DrugView details →

Class IITerminated

Gentell Hydrogel Ag Saturated Gauze, 2"x2"(NDC 61551-112-20), 4x4(NDC 61554-114-24) and 4"x8"(NDC 61554-118-28), Manufactured by: Gentell, 2701 Bartram Road, Bristol, PA 19007

Gentell, Inc

CGMP Deviations

December 15, 2016 · DrugView details →

Class IITerminated

Phenylephrine 2.5% + Tropicamide 1% Compounded Eye Drops Solution, 5 mL bottles, Meta Pharmacy Services. NDC 99999-0106-99 Sterile compounded drug, Hospital/office use only, Not for resale Storage: ROOM TEMP

Meta Pharmacy Services

Lack of Sterility Assurance

December 15, 2016 · DrugView details →

Class IITerminated

Torsemide Tablets, 5 mg 100-count bottle, Rx only ,Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9W, 6Y3, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-0232-01

Apotex Corp.

CGMP Deviations

December 14, 2016 · DrugView details →

Class IITerminated

Torsemide Tablets, 20 mg 100-count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9W, 6Y3, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-0234-01

Apotex Corp.

CGMP Deviations

December 14, 2016 · DrugView details →

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