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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 4121–4140 of 17,755 recalls

Class IITerminated

Extra Strength (ES) PAIN RELIEVER (acetaminophen 500 mg) 2 tablet packets, Manufactured by Ultratab Laboratories, Inc.

Ultra Seal Corporation

cGMP deviations

January 24, 2022 · DrugView details →

Class IITerminated

PEPTIME Energy (caffeine 250mg) tablets, 100-count bottles, Marketed by: DMD Pharmaceuticals, A Division of Dickery Consumer Products, Inc., Noblesville, IN 46060.

Ultra Seal Corporation

cGMP deviations

January 24, 2022 · DrugView details →

Class II

Terminated

EXTRA STRENGTH UN-ASPIRIN (acetaminophen 500 mg) 2 Caplet packets, Dist. by ZEE Medical Distributors, LLC Mason, OH 45040, NDC 42961-041-03

Ultra Seal Corporation

cGMP deviations

January 24, 2022 · DrugView details →

Class IITerminated

MAGNACAL (calcium carbonate 420 mg), 2 tablet packets, Manufactured for: Afassco Inc. Minden, NV 89423

Ultra Seal Corporation

cGMP deviations

January 24, 2022 · DrugView details →

Class IITerminated

Exaprin pain reliever (acetaminophen 110 mg, aspirin 162 mg, caffeine 32.4mg, salicylamide 152mg) tablets, 2- tablet packets, Manufactured for: HARTHealth Seattle, WA 98124

Ultra Seal Corporation

cGMP deviations

January 24, 2022 · DrugView details →

Class IITerminated

SINU-PHEN PLUS sinus pain and congestion tabs (acetaminophen 500 mg, Phenylephrine HCl 5.0 mg) 2 tablet packets, Manufactured for: Tellus Medical Products, Palm Desert, CA 92211, NDC 69103-2536-00

Ultra Seal Corporation

cGMP deviations

January 24, 2022 · DrugView details →

Class IITerminated

Cold Relief Severe Pain/Cough (acetaminophen 325mg, Dextromethorphan HBr 15mg, Guaifenesin 200mg, phenylephrine HCl 5mg), 2-tablet packets, Manufactured for Select Corporation, Carrollton, TX 75007

Ultra Seal Corporation

cGMP deviations

January 24, 2022 · DrugView details →

Class IITerminated

AYPANAL Non-aspirin Pain Reliever (acetaminophen 325 mg) tablets, 2-count packets, Dist. by Honeywell Safety Products USA, Smithfield, RI 02917

Ultra Seal Corporation

cGMP deviations

January 24, 2022 · DrugView details →

Class IITerminated

Regular Strength Pain Reliever (acetaminophen 110 mg, aspirin 162 mg, Caffeine 32.4 mg, Salicylamide 152 mg) 2 tablet packets, Mfg for Advanced First Aid, Baltimore, MD 21237, NDC 67060-0113-00

Ultra Seal Corporation

cGMP deviations

January 24, 2022 · DrugView details →

Class IITerminated

Cold Tablet Pain Reliever/Fever Reducer/Expectorant/Nasal Decongestant (acetaminophen 325 mg, Guaifenesin 200mg, Phenylephrine HCl 5 mg) 2 tablets per packet, Mfg, for Respond Industries and American First Aid, Mason, OH 45040

Ultra Seal Corporation

cGMP deviations

January 24, 2022 · DrugView details →

Class IITerminated

SINUS DECONGESTANT Nasal Decongestant (phenylephrine HCl 5mg) tablets, 2-count packets, Dist. by Honeywell Safety Products USA, Smithfield, RI 02917

Ultra Seal Corporation

cGMP deviations

January 24, 2022 · DrugView details →

Class IITerminated

REMfresh Advanced Ion-Powered Melatonin (Melatonin 5 mg) Caplets, packaged in 36-count blisters Physician's Seal LLC, Boca Raton, FL 33487

Ultra Seal Corporation

cGMP deviations

January 24, 2022 · DrugView details →

Class IITerminated

CETAFEN COUGH & COLD COUGH & COLD RELIEF (Acetaminophen 325 mg, Dextromethorphan HBr 15mg, Guaifenesin 200mg, phenylephrine HCl 5mg) Coated tablets, 2-count packets, Manufactured for: HARTHealth Seattle, WA 98124

Ultra Seal Corporation

cGMP deviations

January 24, 2022 · DrugView details →

Class IITerminated

ELECTROLYTE Supplement Tablets (calcium 5.2 mg, Potassium 20.8 mg, Magnesium 6 mg ) 2-count packets, Dist. by Honeywell Safety Products USA, Smithfield, RI 02917

Ultra Seal Corporation

cGMP deviations

January 24, 2022 · DrugView details →

Class IITerminated

Multi-Symptom Cramp Relief (acetaminophen 325mg and Pamabrom 25mg), 2- tablet packets, Mfd. for First Aid Direct, Mason, OH 45040

Ultra Seal Corporation

cGMP deviations

January 24, 2022 · DrugView details →

Class IITerminated

Proctofoam HC (hydrocortisone acetate 1% and pramoxine hydrochloride 1%) topical aerosol, 10 g aerosol containers, Rx Only, Distributed by Meda Pharmaceuticals Inc, Somerset, New Jersey 08873-1120, NDC 0037-6822-10.

Mylan Pharmaceuticals Inc

cGMP deficiencies

January 21, 2022 · DrugView details →

Class IIITerminated

Azacitidine, 1,00mg/Vial, One Single-dose Vial, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Visakhapatnam - 530 046, India, NDC 43598-305-62

Dr. Reddy's Laboratories, Inc.

Failed stability specifications

January 19, 2022 · DrugView details →

Class IIITerminated

Azacitidine, 100mg/vial, One Single-dose Vial, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Visakhapatnam - 530 046, India, NDC 43598-465-62

Dr. Reddy's Laboratories, Inc.

Failed stability specifications

January 19, 2022 · DrugView details →

Class IIITerminated

Bortezomib, 3.5 mg/vial, Single-Dose Vial, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Visakhapatnam - 530 046, India, NDC 43598-865-60

Dr. Reddy's Laboratories, Inc.

Failed stability specifications

January 19, 2022 · DrugView details →

Class IITerminated

Doxylamine Succinate and Pyridoxine Hydrochloride Delayed-Release Tablets 10 mg/10 mg, 100-count bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 007045 USA, NDC 0591-2132-01

Teva Pharmaceuticals USA

Failed Dissolution Specification: Dissolution results are below specification limits for the active ingredient

January 18, 2022 · DrugView details →

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