🍔 Food 💊 Drugs 🏥 Medical Devices
Clobazam Tablets 10mg, 100-count bottle, Rx Only, Manufactured by: Micro Labs Limited Goa-403 722, India. Manufactured for: Micro Labs USA, Inc. Somerset, NJ 08873. NDC 42571-315-01 Class II

Reason: CGMP Deviations: Out of specification for residual solvents.

Micro Labs Limited 20240212 Ongoing
Distributed: Nationwide in the USA
View Details
CABTREO (clindamycin phosphate, adapalene and benzoyl peroxide) Topical Gel 1.2%/0.15%/3.1%, Not for Oral, Ophthalmic or Intravaginal Use, Rx Only, Net Wt. 50g, Distributed by Bausch Health US, LLC Bridgewater, NJ 08807 USA, Manufactured by: Bausch Health Companies, Inc. Laval Quebec H7L 448, Canada, NDC 0187-0006-25. Class II

Reason: CGMP Deviations: Product was stored outside labeled storage temperature requirements. Product was exposed to controlled room temperature environment instead of remaining refrigerated.

MCKESSON CORPORATION 20240212 Terminated
Distributed: Nationwide in the US
View Details
TING 1% Tolnaftate Athlete's Foot Spray Antifungal Spray Liquid, NET WT 4.5 oz. (128 g) cans, Distributed by: Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company, Tarrytown, NY 10591 UPC 3 63736 81961 3 Class I

Reason: Chemical Contamination; presence of benzene.

Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company 20240201 Completed
Distributed: Product was distributed nationwide and to 4 foreign accounts. Guaynabo, Puerto Rico; Georgetown, Guyana; Baghdad, Iraq; Accra, Ghana.
View Details
Arize Herbal Dietary Supplement, packaged in 10 capsules per box, Distributed by: Natural Herbal Remedies, LLC, Cheyenne, WY 82001, www.getarize.com Class I

Reason: Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared nortadalafil, an ingredient found in FDA approved product for the treatment of male sexual enhancement, making this drug an unapproved drug.

Today The World 20240206 Ongoing
Distributed: Product distributed nationwide within the United States.
View Details
SCHWINNNG Herbal Dietary Supplement, packaged in 10 capsules per box, Distributed by: Today the World LLC, Vancouver, WA 98683 Class I

Reason: Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared nortadalafil, an ingredient found in FDA approved product for the treatment of male sexual enhancement, making this drug an unapproved drug.

Today The World 20240206 Ongoing
Distributed: Product distributed nationwide within the United States.
View Details
Sustain Herbal Dietary Supplement, packaged in 10 capsules per box, Distributed by VSD Productions, Inc. Las Vegas, Nevada Class I

Reason: Marketed Without An Approved NDA/ANDA: FDA analysis found this product to be tainted with undeclared tadalafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this drug an unapproved drug.

Today The World 20240206 Ongoing
Distributed: Product distributed nationwide within the United States.
View Details
Adrenalin (epinephrine) Injection 1mg/mL, 1mL single dose vial, Rx only, Packaged By: Henry Schein, Inc., 80 Summit View Lane, Bastian, VA 24314, Original NDC 42023-159-25 Repack NDC 0404-9810-01 Class II

Reason: Labeling: Incorrect or Missing Lot and/or Exp Date. The expiration date listed on the Repack Pouch Label is incorrect.

Henry Schein Inc. and Glove Club HSI Gloves Inc. 20240117 Completed
Distributed: USA nationwide.
View Details
Terlivaz (terlipressin for injection), 0.85mg/vial, Single-Dose Vial, Rx only, Distributed by: Mallinckrodt Hospital Products Inc., Bridgewater, NJ 08807, USA, NDC 43825-200-01 Class II

Reason: cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified.

Mallinckrodt Hospital Products Inc. 20240206 Ongoing
Distributed: USA nationwide
View Details
Acthar Gel (repository corticotropin injection) 400 USP units/5mL (80 USP units/mL), 5mL multiple-dose vial, Rx only, Mfd. for: Mallinckrodt ARD LLC, Bridgewater, NJ 08807, NDC 63004-8710-1 Class II

Reason: cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified.

Mallinckrodt Hospital Products Inc. 20240206 Ongoing
Distributed: USA nationwide
View Details
Fosfomycin Tromethamine Granules for Oral Solution, (equivalent to 3 grams of fosfomycin), single-dose sachet, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA. Distributed by: Ascend Laboratories, LLC. Parsippany, NJ 07054. NDC 67877-749-57 Class II

Reason: Failed Impurities/Degradation Specification: Out of specification for organic impurities

Ascend Laboratories, LLC 20240116 Ongoing
Distributed: Nationwide in the USA
View Details
Page 192 of 1,805 | Showing 10 recalls
Data provided by openFDA