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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 5461–5480 of 17,755 recalls

Class IITerminated

White Liniment packaged in a) 1 oz; b) 4 oz.; and c) 6 oz bottles. Mfg & Sold by: H & H Remedies, LLC c/o David A. Cox, 1219 South Broadway, New Philadelphia, OH 44663

H & H Remedies, LLC

CGMP Deviations

October 21, 2020 · DrugView details →

Class IITerminated

Union (black) salve packaged in a) 1/8 oz; b) 2 oz.; c) 4 oz.; d) 8 oz.; e) 16 oz.; and f) 32 oz. jars. Mfg & Sold by: H & H Remedies, LLC c/o David A. Cox, 1219 South Broadway, New Philadelphia, OH 44663

H & H Remedies, LLC

CGMP Deviations

October 21, 2020 · DrugView details →

Class IITerminated

Metformin HCL E/R 500 mg, 90 Tabs, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 NDC 72189-064-90

Direct Rx

CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)

October 12, 2020 · DrugView details →

Class IITerminated

Metformin Hydrochloride Extended Release 750 mg, 30 count blister cards, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA NDC 70518-2480-00

RemedyRepack Inc.

CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)

October 11, 2020 · DrugView details →

Class IITerminated

N-A-C (N-Acetyl-L-Cysteine, 500 mg, 100 capsules; Veggie Caps, white HDPE bottle with RED label Product # 107002 UPC: 790011070023

Jarrow Formulas Inc

Mislabeling of SUS (N-A-C Sustain 600 mg 100 tab) with N-A-C N-Acetyl-L-Cysteine 500 mg, 100 cap.

October 9, 2020 · DrugView details →

Class IITerminated

DCL B Prox10 Anti-Blemish Wash (Benzoyl Peroxide 10%), 200 ml/6.7 fl.oz. Dermatologic Cosmetic Laboratories, East Haven, CT 06512 USA, UPC 0357486500853

Milbar Laboratories, Inc.

GMP Deviations

October 9, 2020 · DrugView details →

Class IITerminated

DCL T Shampoo for Hair and Body ( Solution Coal Tar U.S.P. 3% and 0.6% Coal Tar), 300 ml/ 10.1 fl.oz. Dermatologic Cosmetic Laboratories, East Haven, CT 06512 USA, UPC 3574865069947

Milbar Laboratories, Inc.

GMP Deviations

October 9, 2020 · DrugView details →

Class IITerminated

Salicylic Acid Shampoo 3%, Bulk Product, 360 Therapeutics

Milbar Laboratories, Inc.

GMP Deviations

October 9, 2020 · DrugView details →

Class IITerminated

(Malin + Goetz) dandruff Shampoo Psoriasis and Sebborrheic Dermatitis (1.9% Pyrithione Zinc) 8 fl.oz bottle, Distributed by: Malin+Goetz Inc 330 Seventh Avenue, New York, New York, 10001

Milbar Laboratories, Inc.

GMP Deviations

October 9, 2020 · DrugView details →

Class IIITerminated

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixed Salts of A Single-Entity Amphetamine Product) Extended-Release Capsules, 25 mg, 100-count bottle, Rx Only, Mfd. for: Amerigen Pharmaceuticals, Inc. Lyndhurst, NJ 07071 NDC 43975-281-10

ANI Pharmaceuticals, Inc.

Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.

October 9, 2020 · DrugView details →

Class IIITerminated

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixed Salts of A Single-Entity Amphetamine Product) Extended-Release Capsules, 20 mg, 100-count bottle, Rx Only, Mfd. for: Amerigen Pharmaceuticals, Inc. Lyndhurst, NJ 07071 NDC 43975-280-10

ANI Pharmaceuticals, Inc.

Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.

October 9, 2020 · DrugView details →

Class IITerminated

Willa Pore Perfector (Salicylic Acid 2%) pads, 30 pads

Milbar Laboratories, Inc.

GMP Deviations

October 9, 2020 · DrugView details →

Class IITerminated

DCL Clear Skin Anti-Blemish Hydrator (2% Salicylic Acid), 50ml/1.7 fl. oz, Dermatologic Cosmetic Laboratories, East Haven, CT 06512 USA

Milbar Laboratories, Inc.

GMP Deviations

October 9, 2020 · DrugView details →

Class IITerminated

DCL Alpha Beta Gel Toner (1.95% Salicylic Acid) 200 mL/6.7 fl. oz, Dermatologic Cosmetic Laboratories, East Haven, CT 06512 USA

Milbar Laboratories, Inc.

GMP Deviations

October 9, 2020 · DrugView details →

Class IIITerminated

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixed Salts of A Single-Entity Amphetamine Product) Extended-Release Capsules, 30 mg, 100-count bottle, Rx Only, Mfd. for: Amerigen Pharmaceuticals, Inc. Lyndhurst, NJ 07071 NDC 43975-282-10

ANI Pharmaceuticals, Inc.

Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.

October 9, 2020 · DrugView details →

Class IITerminated

DCL AHA Lightening Gel (hydroquinone 2%), 30 ml/1 fl.oz. Dermatologic Cosmetic Laboratories, East Haven, CT 06512 USA, UPC 357486500471

Milbar Laboratories, Inc.

GMP Deviations

October 9, 2020 · DrugView details →

Class IIITerminated

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixed Salts of A Single-Entity Amphetamine Product) Extended-Release Capsules, 15 mg, 100-count bottle, Rx Only, Mfd. for: Amerigen Pharmaceuticals, Inc. Lyndhurst, NJ 07071 NDC 43975-279-10

ANI Pharmaceuticals, Inc.

Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.

October 9, 2020 · DrugView details →

Class IITerminated

Willa Clear Skin (Salicylic Acid 2%), 4.2 fl oz 124ml tubes, WBC Group LLC, Dist. Chandler, AZ 85226

Milbar Laboratories, Inc.

GMP Deviations

October 9, 2020 · DrugView details →

Class IIITerminated

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixed Salts of A Single-Entity Amphetamine Product) Extended-Release Capsules, 5 mg, 100-count bottle, Rx Only, Mfd. for: Amerigen Pharmaceuticals, Inc. Lyndhurst, NJ 07071 NDC 43975-277-10

ANI Pharmaceuticals, Inc.

Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.

October 9, 2020 · DrugView details →

Class IITerminated

MD Complete Breakout Treatment (Benzoyl Peroxide 4.5%) 1 fl. oz. (30mL) bottles, MD Professional LLC, Minneapolis, MN

Milbar Laboratories, Inc.

GMP Deviations

October 9, 2020 · DrugView details →

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