1,709 recalls · Class III, newest first
Reason Labeling: Label lacks warning or Rx legend; Certain information was inadvertently excluded from the product carton label.
Reason Superpotent (Single Ingredient Drug): salicylic acid
Reason Labeling: Not elsewhere classified: On 12/12/11, DEA published a final rule in the Federal Register making this product a schedule IV…
Reason Lack of Assurance of Sterility; potential that a low level of endotoxins may be present in the diluent vials.
Reason Subpotent; 22 month stability timepoint
Reason Subpotent; 12 month stability timepoint
Reason Defective Container: Pump head detaching from the canister unit upon removal of the overcap.
Reason Product Lacks Stability: These lots are being recalled due to the failure to meet the particle size distribution specification.
Reason Product Lacks Stability: These lots are being recalled due to the failure to meet the particle size distribution specification.
Reason Failed Stability Specifications: The active sunscreen ingredient, avobenzone 3%, may not be stable over the shelf life, the sunscreen effectiveness…
Reason Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxide active ingredient. Additionally, this product is…
Reason Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxide active ingredient. Additionally, this product is…
Reason Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the salicylic acid ingredient. Additionally, this product is…
Reason Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the salicyclic acid active ingredient.
Reason Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxide active ingredient. Additionally, this product is…
Reason Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxide active ingredient. Additionally, this product is…
Reason Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxide active ingredient. Additionally, this product is…
Reason Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxide active ingredient. Additionally, this product is…
Reason CGMP Deviations: The products were manufactured with raw material which contain unknown particles believed to be water and dirt.
Reason Short Fill: some bottles contained less than 120-count per labeled claim.
Reason Impurity/Degradation; exceeded impurity specification at the 8 and 15 month time points (betacyclodextrin ester 1&2)
Reason Impurities/Degradation Products: An out of specification result for a known impurity of the product occurred during 12 month stability testing.
Reason Impurities/Degradation Products: An out of specification result for a known impurity of the product occurred during 12 month stability testing.
Reason Labeling Illegible: Some bottles labels have incomplete NDC numbers and missing strength.
Reason Labeling; incorrect or missing insert; Warnings portion of the Package Insert is missing the warning statement: Anaphylaxis has been reported with…