84 recalls · Class III, newest first
Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxide active ingredient. Additionally, this product is mislabeled because the label either omits or erroneously added inactive ingredients to the label.
CGMP Deviations: The products were manufactured with raw material which contain unknown particles believed to be water and dirt.
Short Fill: some bottles contained less than 120-count per labeled claim.
Impurity/Degradation; exceeded impurity specification at the 8 and 15 month time points (betacyclodextrin ester 1&2)
Impurities/Degradation Products: An out of specification result for a known impurity of the product occurred during 12 month stability testing.
Impurities/Degradation Products: An out of specification result for a known impurity of the product occurred during 12 month stability testing.
Labeling Illegible: Some bottles labels have incomplete NDC numbers and missing strength.
Labeling; incorrect or missing insert; Warnings portion of the Package Insert is missing the warning statement: Anaphylaxis has been reported with urinary-derived hCG products.
Labeling: Label Mix-up: Product was incorrectly labeled,"Tabs" instead of "Capsules."
Stability data does not support expiration date: Stability data indicates the Carbamide Peroxide will degrade below acceptable levels within the 24-month expiration date printed on the packaging.
Subpotent; fluocinolone acetonide.
Presence of Particulate Matter; potential for charcoal particulates
Impurities/Degradation Products: Recalled lots do not meet room temperature stability specification for unknown degradant.
Impurities/Degradation Products: Recalled lots do not meet room temperature stability specification for unknown degradant.
Labeling: Correct Labeled Product Miscart/Mispack: labels on outer containers do not match labels on vials (the correct label)
Microbial Contamination of a Non-Sterile Products: Three product lots are contaminated with Burkholderia cepacia.
Labeling: Label Mix-Up: A typographical error in the product form on the carton label incorrectly lists the configuration as 30 "Capsules" (3 x 10) rather than "Tablets".
Labeling: Label Mix-Up; Some bottles of Tizanidine 4mg Tablets, had the incorrect manufacturer (Actavis) printed on the label.
Failed Impurities/Degradation Specifications: Ketoconazole Cream 2% is the subject of a voluntary drug recall by Fougera due to an Out Of Specification result for an unknown degradant product
Labeling; labeled with incorrect EXP Date; Incorrect expiration date printed on the outer packaging. Package incorrectly states 5/2014 should correctly state 4/2014
Impurities/Degradation Products: High Out of Specification results for a known impurity resulted at the 12-month room temperature time point.
Impurities/Degradation Products: Out of specificiation results for impurities at the 18-month room temperature time point.
Failed PH specification: The lots of Carboplatin Injection were manufactured from Carboplatin API lots which trended out of specification low pH.
Adulterated Presence of Foreign Tablets/Capsules: Some bottles may contain a small number of Nexium 20 mg capsules intended for the Japanese market in addtion to Nexium 40 mg capsules.
Impurities/Degradation Products: Out of specification results for Related Compound during routine stability testing.