Class I - Dangerous
CGMP Deviations: Potential Glass and Silicone particulates in product
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Drugs Recalls
Prescription and over-the-counter medications
17,302 Total Recalls
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
Mallinckrodt Hospital Products
Class I - Dangerous
cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified.
Class I - Dangerous
Incorrect product concentration on the overwrap label: The overwrap label incorrectly identified the product strength as 4 mg / 250 mL; however, the primary bag label correctly identified the product strength as 8 mg / 250 mL.
Class I - Dangerous
Labeling: Incorrect or Missing Package Insert
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
Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company
Class I - Dangerous
Chemical Contamination; presence of benzene.
Neptune's Fix, Tianeptine Elixir, Fast Acting, 0.338 fl oz (10 mL) bottle, Distributed By Neptune Resources, LLC, 30 N. Gould Street, Ste R, Sheridan, WY 82801.
Neptune Resources
Class I - Dangerous
Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.
Class I - Dangerous
CGMP Deviations: potential presence of Burkholderia cepacia complex
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
Henry Schein Inc. and Glove Club HSI Gloves
Class I - Dangerous
Labeling: Incorrect or Missing Lot and/or Exp Date. The expiration date listed on the Repack Pouch Label is incorrect.
Class I - Dangerous
Failed Impurities/Degradation Specification: Out of specification for organic impurities
SCHWINNNG Herbal Dietary Supplement, packaged in 10 capsules per box, Distributed by: Today the World LLC, Vancouver, WA 98683
Today The World
Class I - Dangerous
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.
Sustain Herbal Dietary Supplement, packaged in 10 capsules per box, Distributed by VSD Productions, Inc. Las Vegas, Nevada
Today The World
Class I - Dangerous
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.
Class I - Dangerous
Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.
Vasopressin 2 Units/2 mL in 0.9% Sodium Chloride Sterile Syringe for Injection, Concentration: 1 Unit/mL, 2 mL Syringe, Rx Only, 719 Kasota Ave SE, Minneapolis, MN, Compounded Drug Not for Resale. Office Use Only, NDC 71139-0190-1.
IntegraDose Compounding Services
Class I - Dangerous
Sub-potent drug: failure to maintain potency through the duration of the labeled expiration/beyond-use date.
HydrALAZINE Hydrochloride Tablets, USP 10mg, packaged in 100-count (10x10 blister cards), Lot T04680, Rx only, Manufactured for Heritage Pharmaceuticals, Inc. Eatontown, NJ, Distributed by Major Pharmaceuticals Livonia MI. NDC 0904-6440-61
The Harvard Drug Group LLC
Class I - Dangerous
an out of specification result obtained during routine stability testing for Impurities. There is a remote possibility that use of this product could cause a medically reversible or transient adverse health consequences.
Class I - Dangerous
Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.
Up&Up brand dry eye relief (Carboxymethylcellulose 0.5%) packaged in 0.5 FL OZ (15 mL) each bottles (Twin Pack), Distributed by: Target Corporation Minneapolis, MN 55403, NDC 76168-800-30
Kilitch Healthcare India Limited
Class I - Dangerous
Non-Sterility
Velocity Pharma brand Lubricating Eye Drop (Propylene glycol Eye Drops 0.6%), packaged in 3 bottles of 0.33 FL OZ (10 mL) each, Velocity Pharma, NDC 76168-502-30
Kilitch Healthcare India Limited
Class I - Dangerous
Non-Sterility
CVS Health brand Lubricant Eye Drops (Carboxymethylcellulose Sodium 0.5%), packaged in a) 0.5 FL OZ (15mL) bottles (Single Pack) (NDC 76168-702-15) and b) 0.5 FL OZ (15 mL) bottles (Twin pack) (NDC 76168-702-30), Distributed by: CVS Pharmacy Inc. One CVS Drive Woonsocket, RI 02895.
Kilitch Healthcare India Limited
Class I - Dangerous
Non-Sterility
Target brand High Performance Lubricant Eye Drops (Polyethylene glycol 400 0.4%, Propylene glycol 0.3%) a) 0.5 FL OZ (15mL) bottles (Single Pack) (NDC 11673-522-15) and b) 0.5 FL OZ (15 mL) bottles (Twin pack) (NDC 11673-522-30), Distributed by: Target Corporation Minneapolis, MN 55403
Kilitch Healthcare India Limited
Class I - Dangerous
Non-Sterility
CVS Health brand Mild Moderate Lubricating Eye Drops (Propylene glycol 400 0.25%), packaged in 0.5 FL OZ (15 mL) bottles, Distributed by: CVS Pharmacy Inc. One CVS Drive Woonsocket, RI 02895. NDC 76168-711-15
Kilitch Healthcare India Limited
Class I - Dangerous
Non-Sterility