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FDA Recalls

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›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 201–220 of 1,000 recalls

Class IIITerminated

Vica-Cet BACK PAIN RELIEF (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 tablets/pk, packaged in 10,000 packets, PO# 8967, Mfg. for Tellus/The Provision First Aid Line (Shipping Label)

Ultra Seal Corporation

Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.

October 13, 2021 · DrugView details →

Class IIITerminated

ZEE+ painaid ESF Extra-Strength Formula (Acetaminophen 250 mg, Aspirin 250 mg (NSAID), Caffeine 65 mg) tablets, 2 Tablets per/package, Packaged in a) 50-count packages/carton, b) 125-count packages/carton, PA-ESF 1414Z, Dist. by: Zee Medical Distributors, LLC Mason, OH 45040 (Shipping Label)

Ultra Seal Corporation

Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.

October 13, 2021 · Drug

View details →

Class IIITerminated

AERO Tab PAIN RELIEVER (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets , 2 tablets Per Packet, Packaged in 10,000 Packets/Case, PO# 11938, Mfg. for: Aero Healthcare, Valley Cottage, NY 10989 (Shipping Label )

Ultra Seal Corporation

Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.

October 13, 2021 · DrugView details →

Class IIITerminated

North by Honeywell PAIN STOPPER EXTRA STRENGTH (Acetaminophen 250 mg, Aspirin 250 mg, Caffeine 65 mg) tablets, 2 tablets per packet, Packaged in 5,000 Packets/Case, PO# B121242, Item# 853500-01, Dist. By Honeywell Safety Products USA, Smithfield, RI 02917

Ultra Seal Corporation

Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.

October 13, 2021 · DrugView details →

Class IIITerminated

Xpect First aid Extra Strength PAIN AWAY (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 Tablets/package, Packaged in 12,000 Packets/Case, Material# 111519, Mfg. for: Cintas First Aid & Safety, Mason, OH 45040 (Shipping Label)

Ultra Seal Corporation

Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.

October 13, 2021 · DrugView details →

Class IIITerminated

PainAway II (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets , 2 tablets/pk, packaged in 12,000 Packets/Case, Material # 11161, Mfg. for Respond Industries First Aid, Mason, OH 45040 (Shipping Label)

Ultra Seal Corporation

Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.

October 13, 2021 · DrugView details →

Class IIITerminated

AllerClear D-24 hr, (Loratadine and Pseudoephedrine Sulfate, Extended-Release Tablets, USP 10/240mg), 15-count blister packs, Manufactured by: Ohm Laboratories Inc., 1385 Livingston Avenue, North Brunswick, NJ 08902, NDC 63981-724-15

SUN PHARMACEUTICAL INDUSTRIES INC

Failed Moisture Limits

October 12, 2021 · DrugView details →

Class IIITerminated

Loratadine-D Extended-Release Tablets (Loratadine and Pseudoephedrine Sulfate, Extended-Release Tablets, USP 10mg/240mg) , 10-count blister packs, Distributed By Major Pharmaceuticals, 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152, NDC 0904-5833-15

SUN PHARMACEUTICAL INDUSTRIES INC

Failed Moisture Limits

October 12, 2021 · DrugView details →

Class IIITerminated

Cetirizine hydrochloride, 10 mg tablets, 90-count bottle, Distributed by: A-S Medications Solutions, Libertyville, IL 60048, Mfg: Major Pharmaceuticals, Livonia, MI 48152, NDC: 50090-5510-3

A-S Medication Solutions LLC.

Labeling: Not Elsewhere classified: Product was relabeled as 90 tablet count product although it was a manufacturer in a box with 30 tablet count tablets.

October 5, 2021 · DrugView details →

Class IIITerminated

Candesartan Cilexetil Tablets, USP 16 mg, 30 count bottles, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 NDC 0378-3231-93

Viatris

Failed Impurities/Degradation Specifications; out of specification for Related Compound

September 13, 2021 · DrugView details →

Class IIITerminated

Glycopyrrolate Injection, USP 4mg per 20mL, 20 mL Multi-Dose Vials, Rx only, Mfd for Meitheal Pharmaceuticals, Chicago, IL 60631. NDC 71288-408-21

Meitheal Pharmaceuticals Inc

Failed Impurities/Degradation Specifications

September 3, 2021 · DrugView details →

Class IIITerminated

CVS Health Daytime Severe Cold & Flu Relief Single-Use Vials Mixed Berry Flavor 8 Pre-Measured Vials 0.51 FL OZ (15 mL) Each 4.06 FL OZ (120 mL) Total NDC 69842-499-08 UPC 0 50428 64130 9 Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895

New Vision Pharmaceuticals LLC

Subpotent Drug

September 2, 2021 · DrugView details →

Class IIITerminated

Daytime Severe Cold & Flu Relief 8 Pre-Measured Vials 0.51 FL OZ (15 mL) Each 4.06 FL OZ (120 mL) Total/Nighttime Severe Cold & Flu Relief 8 Pre-Measured Vials 1.01 FL OZ (30 mL) Each 8.12 FL OZ (240 mL) Total Single-Use Vials Mixed Berry Flavor NDC 69842-495-16 UPC 0 50428 64057 9 Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895

New Vision Pharmaceuticals LLC

Subpotent Drug

September 2, 2021 · DrugView details →

Class IIITerminated

Hydroquinone, USP, 4% Skin Bleaching Cream, packaged in 1 oz (28.35g) tube, Rx only, Manufactured for: Westminster Pharmaceuticals, LLC Nashville, TN 37217, NDC 69367-174-01 UPC 3 69367 17401 5

Monarch PCM, LLC

Subpotency: one product for active ingredient assay and another one for preservative assay

September 1, 2021 · DrugView details →

Class IIITerminated

Sodium Sulfacetamide, 10%, Wash, packaged in bottles: a) 6 fl oz (177 mL) NDC 42808-103-06 UPC 3 42808 10306 5; b) 12 fl oz (354.8 mL) NDC 42808-103-12 UPC 3 42808 10312 6, Rx only, Manufactured in the U.S.A. for Exact-Rx, Inc., Melville, NY 11747

Monarch PCM, LLC

Subpotency: one product for active ingredient assay and another one for preservative assay

September 1, 2021 · DrugView details →

Class IIITerminated

Donepezil HCL Tablets, USP, 5 mg, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd. India, Marketed by: Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD 21801 NDC 59746-329-90

Jubilant Cadista Pharmaceuticals, Inc.

Subpotent

August 20, 2021 · DrugView details →

Class IIITerminated

Bleomycin for Injection, USP, packaged in 15 units per single dose vial, Rx only, Manufactured by Thymoorgan Pharmazie GmbH Schiffgraben 23, 38690 Gosfar, Germany Distributed by Hikma USA Inc. Berkeley Heights, NJ 07922, NDC 0143-9240-01

Hikma Pharmaceuticals USA Inc.

Labeling: Not elsewhere classified: Mislabeling

August 5, 2021 · DrugView details →

Class IIITerminated

Avicel, Mirocrystalline cellulose, packaged in bulk as PH101 NF, PH102 NF, PH200 NF, Manufactured by: DuPont Nutrition USA, Inc., 1301 Ogletown Road, Newark, DE 19711

DuPont Nutrition USA, Inc

Out of specification results for conductivity.

August 5, 2021 · DrugView details →

Class IIITerminated

Lidocaine Ointment USP, 5% Rx Only, Net Wt 35.44 g(1 1/4 oz)packaged in a laminat tube, Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-008-14.

Teligent Pharma, Inc.

Failed Viscosity Specifications: lot does not meet specification for Viscosity, which was determined through routine testing.

July 29, 2021 · DrugView details →

Class IIITerminated

Acetaminophen EXTRA STRENGTH Pain Reliever / Fever Reducer, Enteric Coated, 50 Coated Tablets/ 500 mg each, Distributed by Amerisource Bergen, 1300 Morris Drive, Chesterbrook, PA, 19087, NDC 46122-649-71

LNK International, Inc.

Labeling: Not Elsewhere Classified The primary label contains the words "enteric coated" but the tablet is not enteric coated and should only say 'coated tablet'

July 7, 2021 · DrugView details →

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