November 25, 2020DrugsFDA
Ascent Pharmaceuticals, Inc. recalls Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325mg 100-count bottles, Rx Only, Manufactured for : Camber
Hazard: Presence of Foreign Tablet/Capsule: One bottle of Hydrocodone Bitartrate and Acetaminophen Tablets USP 10mg/325 mg contains one Losartan Potassium Tablets, USP 100 mg.
November 25, 2020DrugsFDA
Milbar Laboratories, Inc. recalls Salicylic Acid Shampoo 3%, Bulk Product, 360 Therapeutics
Hazard: GMP Deviations
November 25, 2020DrugsFDA
Milbar Laboratories, Inc. recalls DCL Clear Skin Anti-Blemish Hydrator (2% Salicylic Acid), 50ml/1.7 fl. oz, Dermatologic Cosmetic Laboratories, East Have
Hazard: GMP Deviations
November 25, 2020DrugsFDA
Milbar Laboratories, Inc. recalls DCL Alpha Beta Gel Toner (1.95% Salicylic Acid) 200 mL/6.7 fl. oz, Dermatologic Cosmetic Laboratories, East Haven, CT 06
Hazard: GMP Deviations
November 25, 2020DrugsFDA
Milbar Laboratories, Inc. recalls Willa Pore Perfector (Salicylic Acid 2%) pads, 30 pads
Hazard: GMP Deviations
November 25, 2020DrugsFDA
Milbar Laboratories, Inc. recalls Willa Clear Skin (Salicylic Acid 2%), 4.2 fl oz 124ml tubes, WBC Group LLC, Dist. Chandler, AZ 85226
Hazard: GMP Deviations
November 25, 2020DrugsFDA
Milbar Laboratories, Inc. recalls MD Complete Breakout Treatment (Benzoyl Peroxide 4.5%) 1 fl. oz. (30mL) bottles, MD Professional LLC, Minneapolis, MN
Hazard: GMP Deviations
November 25, 2020DrugsFDA
Milbar Laboratories, Inc. recalls (Malin+Goetz) spf 30 face moisturizer (Avobenzone 3%, Homosalate 10 %, Octinoxate 7.5%, Octisalate 2.75%, Oxybenzone 5%)
Hazard: GMP Deviations
November 25, 2020DrugsFDA
Milbar Laboratories, Inc. recalls (Malin + Goetz) Salicylic Gel (2% Salicylic Acid) 0.5 fl.oz. 15 mL tube, Distributed by: Malin+Goetz Inc 330 Seventh Ave
Hazard: GMP Deviations
November 25, 2020DrugsFDA
Milbar Laboratories, Inc. recalls (Malin + Goetz) dandruff Shampoo Psoriasis and Sebborrheic Dermatitis (1.9% Pyrithione Zinc) 8 fl.oz bottle, Distributed
Hazard: GMP Deviations
November 25, 2020DrugsFDA
Milbar Laboratories, Inc. recalls 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 Cosme
Hazard: GMP Deviations
November 25, 2020DrugsFDA
Milbar Laboratories, Inc. recalls DCL SA Scalp Therapy Shampoo (Salicylic Acid 3%) 300 ml/10.1 fl.oz. Dermatologic Cosmetic Laboratories, East Haven, CT 0
Hazard: GMP Deviations
November 25, 2020DrugsFDA
Milbar Laboratories, Inc. recalls DCL AHA Lightening Gel (hydroquinone 2%), 30 ml/1 fl.oz. Dermatologic Cosmetic Laboratories, East Haven, CT 06512 USA, U
Hazard: GMP Deviations
November 25, 2020DrugsFDA
Milbar Laboratories, Inc. recalls DCL B Prox10 Anti-Blemish Wash (Benzoyl Peroxide 10%), 200 ml/6.7 fl.oz. Dermatologic Cosmetic Laboratories, East Haven,
Hazard: GMP Deviations
November 25, 2020DrugsFDA
Milbar Laboratories, Inc. recalls DCL Active Mattifying Cleanser (Salicylic Acid 2%), 125mL/4.2 fl.oz. Dermatologic Cosmetic Laboratories, East Haven, CT
Hazard: GMP Deviations
November 25, 2020DrugsFDA
Albek De Mexico S.A. De C.V. recalls NEXT ADVANCED ANTIBACTERIAL HAND SANITIZER (Ethyl Alcohol 70%), 8 FL OZ (236 ML) bottle, Made in Mexico, Distributed by:
Hazard: 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.
November 25, 2020DrugsFDA
Albek De Mexico S.A. De C.V. recalls Assured Instant Hand Sanitizer Vitamin E and Aloe (Ethyl Alcohol 70% v/v), 8 fl oz/ 237 mL bottle, Distributed By: Green
Hazard: 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.
November 25, 2020DrugsFDA
Albek De Mexico S.A. De C.V. recalls Assured Instant Hand Sanitizer Aloe & Moisturizers (Ethyl Alcohol 70% v/v) 8 fl oz / 237 mL bottle, Distributed By: Gree
Hazard: 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.
November 25, 2020DrugsFDA
Albek De Mexico S.A. De C.V. recalls Modesa INSTANT HAND SANITIZER with Moisturizers and Aloe Vera (ethyl alcohol 70% v/v) 8 fl oz (237 mL) bottle, Distribut
Hazard: 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.
November 25, 2020DrugsFDA
Albek De Mexico S.A. De C.V. recalls NuuxSan Instant ANTIBACTERIAL HAND SANITIZER, 70% Ethyl Alcohol (ethyl alcohol 70%), 8 fl oz. 237 mL bottle, Distributed
Hazard: 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.
November 25, 2020DrugsFDA
Preferred Pharmaceuticals, Inc. recalls Metformin HCl Extended Release Tablets USP 500 mg, Generic for : Glucophage XR, Pkg Size 100, Mfg: Time-Cap Labs, Inc.;
Hazard: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
November 18, 2020DrugsFDA
Baxter Healthcare Corporation recalls Bupivacaine Hydrochloride in 8.25% Dextrose Injection, USP Spinal 0.75% (15 mg/2 mL) 10 x 2 mL single-dose ampules, Rx o
Hazard: Presence of particulate matter in solution - black and transparent particles
November 18, 2020DrugsFDA
H & H Remedies, LLC recalls 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
Hazard: CGMP Deviations
November 18, 2020DrugsFDA
H & H Remedies, LLC recalls 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,
Hazard: CGMP Deviations
November 18, 2020DrugsFDA
H & H Remedies, LLC recalls 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
Hazard: CGMP Deviations
November 18, 2020DrugsFDA
AVKARE Inc. recalls Mesalamine Delayed-Release Tablets, USP 1.2 gram (Once-Daily), 120 Tablets bottle, Rx Only Manufactured for: AvKARE, Inc
Hazard: Failed Dissolution Specifications
November 18, 2020DrugsFDA
Teva Pharmaceuticals USA recalls Mesalamine Delayed-Release Tablets, USP 1.2 gram, 120 tablets per bottle, Rx Only, Manufactured by: Actavis Laboratories
Hazard: Failed Dissolution Specifications: Out-of-specification dissolution results were obtained during stability testing.
November 11, 2020DrugsFDA
Zydus Pharmaceuticals (USA) Inc recalls Lansoprazole Delayed-Release Orally Disintegrating Tablets 30 mg, 100-count carton (10 x10 unit-dose), Rx only, Manufact
Hazard: Failed Dissolution Specification
November 11, 2020DrugsFDA
Zydus Pharmaceuticals (USA) Inc recalls Lansoprazole Delayed-Release Orally Disintegrating Tablets 15 mg, 100-count carton (10 x10 unit-dose), Rx only, Manufact
Hazard: Failed Dissolution Specification
November 11, 2020DrugsFDA
Nostrum Laboratories Inc recalls Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, 100 count bottles, Rx Only. Manufactured by: Nostrum Labor
Hazard: CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level