🔍 RecallPedia

💊

Drugs Recalls

Prescription and over-the-counter medications

17,302 Total Recalls

Assured Instant Hand Sanitizer Vitamin E and Aloe (Ethyl Alcohol 70% v/v), 8 fl oz/ 237 mL bottle, Distributed By: Greenbrier International, Inc. 500 Volvo Parkway, Chesapeake, VA 23320. Made in Mexico, UPC 639277928597

Albek De Mexico S.A. De C.V.

Class I - Dangerous

CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.

Jul 30, 2020 Other Drugs Nationwide View Details →

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

Milbar Laboratories

Class I - Dangerous

GMP Deviations

Oct 9, 2020 Other Drugs View Details →

DCL Active Mattifying Cleanser (Salicylic Acid 2%), 125mL/4.2 fl.oz. Dermatologic Cosmetic Laboratories, East Haven, CT 06512 USA, UPC 357486509627

Milbar Laboratories

Class I - Dangerous

GMP Deviations

Oct 9, 2020 Other Drugs View Details →

DCL SA Scalp Therapy Shampoo (Salicylic Acid 3%) 300 ml/10.1 fl.oz. Dermatologic Cosmetic Laboratories, East Haven, CT 06512 USA, UPC 357486503120

Milbar Laboratories

Class I - Dangerous

GMP Deviations

Oct 9, 2020 Other Drugs View Details →

(Malin + Goetz) Salicylic Gel (2% Salicylic Acid) 0.5 fl.oz. 15 mL tube, Distributed by: Malin+Goetz Inc 330 Seventh Avenue, New York, New York, 10001

Milbar Laboratories

Class I - Dangerous

GMP Deviations

Oct 9, 2020 Other Drugs View Details →

(Malin+Goetz) spf 30 face moisturizer (Avobenzone 3%, Homosalate 10 %, Octinoxate 7.5%, Octisalate 2.75%, Oxybenzone 5%) 1.7 fl. oz. 50 ml tubes, Distributed by: Malin+Goetz Inc 330 Seventh Avenue, New York, New York, 10001

Milbar Laboratories

Class I - Dangerous

GMP Deviations

Oct 9, 2020 Other Drugs View Details →

Vapor Ointment packaged in a) 1/8 oz; b) 2 oz.; c) 4 oz.; and d) 8 oz jars. Mfg & Sold by: H & H Remedies, LLC c/o David A. Cox, 1219 South Broadway, New Philadelphia, OH 44663

H & H Remedies

Class I - Dangerous

CGMP Deviations

Oct 21, 2020 Other Drugs Nationwide View Details →

Mesalamine Delayed-Release Tablets, USP 1.2 gram (Once-Daily), 120 Tablets bottle, Rx Only Manufactured for: AvKARE, Inc. Pulaski, TN 38478 NDC 42291-564-12

AVKARE

Class I - Dangerous

Failed Dissolution Specifications

Oct 30, 2020 Prescription Drugs Nationwide View Details →

Mesalamine Delayed-Release Tablets, USP 1.2 gram, 120 tablets per bottle, Rx Only, Manufactured by: Actavis Laboratories, FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma Inc., Parsippany, NJ 07054, NDC 0591-2245-22.

Teva Pharmaceuticals USA

Class I - Dangerous

Failed Dissolution Specifications: Out-of-specification dissolution results were obtained during stability testing.

Oct 28, 2020 Prescription Drugs Nationwide View Details →

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

Class I - Dangerous

CGMP Deviations

Oct 21, 2020 Other Drugs Nationwide View Details →

Bupivacaine Hydrochloride in 8.25% Dextrose Injection, USP Spinal 0.75% (15 mg/2 mL) 10 x 2 mL single-dose ampules, Rx only, Manufactured for: Baxter Healthcare Corporation Deerfield, IL 60015 USA, Manufactured by: Baxter Pharmaceuticals India Private Ltd Ahmedabad 382213 India, NDC 36000-092-10

Baxter Healthcare

Class I - Dangerous

Presence of particulate matter in solution - black and transparent particles

Oct 7, 2020 Prescription Drugs Nationwide View Details →

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

Class I - Dangerous

CGMP Deviations

Oct 21, 2020 Other Drugs Nationwide View Details →

Time-Cap Labs, Inc. Metformin Hydrochloride Extended-Release Tablets USP 500 mg, a) 90 count (NDC 49483-623-09) b) 100 count (49483-623-01) c) 500 count (NDC 49483-623-50) and d) 1000 count (NDC 49483-623-10) bottles, Rx Only Manufactured for: Time-Cap Labs, Inc. 7 Michael Avenue Farmingdale, NY 11735, USA, Manufactured by: Marksans Pharma Ltd. Plot No. L-82, L-83, Verna Indl. Estate. Verna Goa-403 722 India NDC 49483-623-50

Marksans Pharma Limited

Class I - Dangerous

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

Oct 2, 2020 Prescription Drugs Nationwide View Details →

Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, 100 count bottles, Rx Only. Manufactured by: Nostrum Laboratories, Inc. Kansas City, MO 64120. NDC 29033-055-01

Nostrum Laboratories

Class I - Dangerous

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

Oct 23, 2020 Prescription Drugs Nationwide View Details →

metformin HCL ER 750 mg Rx only Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 a) 30 tablets NDC: 43063-902-30; b) 60 tablets NDC: 43063-902-60

PD-Rx Pharmaceuticals

Class I - Dangerous

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

Oct 6, 2020 Prescription Drugs View Details →

Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 count bottles, Rx Only. Manufactured by: Nostrum Laboratories, Inc. Kansas City, MO 64120. NDC 29033-056-01

Nostrum Laboratories

Class I - Dangerous

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

Oct 23, 2020 Prescription Drugs Nationwide View Details →

Olanzapine Orally Disintegrating Tablets, 5 mg, 30 count (3x10 unit dose) blister pack, Rx only, Manufactured by: Jubilant Generics, Ltd., Roorkee, India, Marketed by: Jubilant Cardista Pharmaceuticals, Inc., Salisbury, MD NDC 59746-0306-32

Jubilant Cadista Pharmaceuticals

Class I - Dangerous

Subpotent

Oct 26, 2020 Prescription Drugs Nationwide View Details →

Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, a) 30 count (NDC 70934-309-30); b) 60 count (NDC 70934-309-60); c) 90 count (70934-309-90); d) 120 count (NDC 70934-309-98) bottles, Rx Only, Time-Cap Labs Inc. Repackaged by Northwind Pharmaceuticals North Blenheim, NY 12131

Denton Pharma

Class I - Dangerous

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

Oct 8, 2020 Prescription Drugs Nationwide View Details →

Chlorhexidine Gluconate 20% 0012 Medichem, S.A. NDC 53296-0012-0

Medichem S.A.

Class I - Dangerous

Discoloration.

Oct 2, 2020 Other Drugs View Details →

Time-Cap Labs, Inc. Metformin Hydrochloride Extended Release Tablets USP 750 mg, 100 count bottles, Rx Only Manufactured for: Time-Cap Labs, Inc. 7 Michael Avenue Farmingdale, NY 11735, USA Manufactured by: Marksans Pharma Ltd. Plot No. L-82, L-83, Verna Indl. Estate. Verna Goa-403 722 India NDC 49483-624-01

Marksans Pharma Limited

Class I - Dangerous

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

Oct 2, 2020 Prescription Drugs Nationwide View Details →