Class I - Dangerous
Marketed without an Approved NDA/ANDA; FDA analysis has found the product to be tainted with human chorionic gonadotropin, rendering it an unapproved drug
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Other Drugs
💊 Drugs • 3,200 recalls
CLENZIderm M.D. Pore Therapy Salicylic Acid 2% Acne Treatment 5 fl. oz. (148 mL), Valeant Pharmaceuticals North America LLC Distributed by OMP, Inc Long Beach, CA 90806 Made in USA. Product SKU 301876102042, NDC 0187-6102-04
Valeant Pharmaceuticals North America
Class I - Dangerous
Discoloration.
Class I - Dangerous
Discoloration.
Class I - Dangerous
Microbial Contamination of Non-Sterile Products: odor complaint of product due to microbial contamination.
cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection
Class I - Dangerous
cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection
Class I - Dangerous
cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection
cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection
Class I - Dangerous
Presence of Foreign Substance; low concentration of an additional flavoring ingredient, Patchouli oil resulting in complaints of off flavor/scent
A+D Diaper Rash Cream with Dimethicone 1% and Zinc Oxide 10%, Packaged in a) 1.5 oz (42.5g) ( UPC 041100811288), b) 3 oz 85g (UPC 041100811301), c) 4 oz (113g) (UPC 041100811325), Distributed by: Bayer Healthcare LLC, Whippany, NJ 07981
Bayer HealthCare Pharmaceuticals
Class I - Dangerous
Labeling: Incorrect/Undeclared Excipients: Firm is recalling A+D Diaper Rash Cream due to a labeling claim issue.
Class I - Dangerous
CGMP Deviations
Class I - Dangerous
CGMP Deviations
Class I - Dangerous
CGMP Deviations
Class I - Dangerous
CGMP Deviations
Class I - Dangerous
CGMP Deviations
Mesalamine, U.S.P. [CAS 89-57-6] Cambrex Charles City, Inc. Charles City, IA packaged in double lined PE liners inside Poly-lined cardboard drums. Net weight 40 kg
Cambrex Charles City
Class I - Dangerous
Presence of Particulate Matter: Stainless steel in a chemical reactor dissolved into the API solution and was detected in the finished product.
Class I - Dangerous
CGMP Deviations
Class I - Dangerous
CGMP Deviations
Class I - Dangerous
CGMP Deviations: potential contamination of products manufactured on the same equipment and lines as the contaminated product.
Toms of Maine Naturally Dry Natural Powder Antiperspirant Stick, Distributed by: Tom's of Maine, Kennebunk, ME 04043, Made in Canada, Unit UPC: 077326831953 Case UPC: 10077326831950
Les Emballages Knowlton
Class I - Dangerous
Labeling: Label Mix Up- Incorrect back label applied to the product.