1,709 recalls · Class III, newest first
Reason Labeling: Label Mix-up: Product was incorrectly labeled,"Tabs" instead of "Capsules."
Reason Stability data does not support expiration date: Stability data indicates the Carbamide Peroxide will degrade below acceptable levels within the…
Reason Subpotent; fluocinolone acetonide.
Reason Presence of Particulate Matter; potential for charcoal particulates
Reason Impurities/Degradation Products: Recalled lots do not meet room temperature stability specification for unknown degradant.
Reason Impurities/Degradation Products: Recalled lots do not meet room temperature stability specification for unknown degradant.
Reason Labeling: Correct Labeled Product Miscart/Mispack: labels on outer containers do not match labels on vials (the correct label)
Reason Microbial Contamination of a Non-Sterile Products: Three product lots are contaminated with Burkholderia cepacia.
Reason 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)…
Reason Labeling: Label Mix-Up; Some bottles of Tizanidine 4mg Tablets, had the incorrect manufacturer (Actavis) printed on the label.
Reason Failed Impurities/Degradation Specifications: Ketoconazole Cream 2% is the subject of a voluntary drug recall by Fougera due to an Out Of…
Reason Labeling; labeled with incorrect EXP Date; Incorrect expiration date printed on the outer packaging. Package incorrectly states 5/2014 should…
Reason Impurities/Degradation Products: High Out of Specification results for a known impurity resulted at the 12-month room temperature time point.
Reason Impurities/Degradation Products: Out of specificiation results for impurities at the 18-month room temperature time point.
Reason Failed PH specification: The lots of Carboplatin Injection were manufactured from Carboplatin API lots which trended out of specification low pH.
Reason Adulterated Presence of Foreign Tablets/Capsules: Some bottles may contain a small number of Nexium 20 mg capsules intended for the Japanese market…
Reason Impurities/Degradation Products: Out of specification results for Related Compound during routine stability testing.
Reason Labeling: Label Mix-up: The product is being recalled because active ingredient in the Drug Facts box incorrectly states "Active Ingredients…
Reason CGMP Deviations: Shipment of product not approved for release.
Reason Labeling: Label Mix-up: The affected units were labeled incorrectly describing the product as "ointment" instead of "solution."
Reason Chemical Contamination: This product is being recalled because trace amounts of a plasticizer (Di-Octyl Phthalate) may be present in the product.
Reason Impurities/Degradation Products: High Out-of-specification results were obtained for both known and unknown impurities.
Reason Labeling: Label Mix-up: Pitocin storage conditions should be labeled, "Store between 20¿ to 25¿C (68¿ to 77¿F)". Pitocin lot 225867 and part of…
Reason Impurities/Degradation Products: A confirmed out of specification result for Leukine sargramostin lot B18827 occurred at the three month time point.
Reason Subpotent (Multiple Ingredient) Drug: Low out of specification assay results for the hydrocodone bitartrate ingredient was found.