1,523 recalls · Class III, newest first
Reason Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles. If the product is shaken or…
Reason Subpotent Drug: OOS (out of specification) assay result at the 12 month stability time point.
Reason Does Not Meet Monograph: Budesonide may be slightly above or below the specification range.
Reason Does Not Meet Monograph: Budesonide may be slightly above or below the specification range.
Reason Subpotent Drug
Reason Failed Dissolution Specifications; 8-hours for the 18-month stability testing point.
Reason Crystallization: Recall is due to a non-characteristic gritty/sandy texture to the product which is likely due to some crystallization of the product.
Reason Crystallization: Recall is due to a non-characteristic gritty/sandy texture to the product which is likely due to some crystallization of the product.
Reason Failed Impurity/Degradation Specifications due to moisture ingress in individual bottles
Reason Failed Impurity/Degradation Specifications due to moisture ingress in individual bottles
Reason Defective Container: Product lacks tamper evident breakaway band on cap.
Reason Impurities/Degradation Products: Out-of-specification results were obtained for a known impurities.
Reason Impurities/Degradation Products: Out of Specification results found for impurity B, identified as the drug's metabolite.
Reason Labeling: Label Error On Declared Strength; Some bottles of product were missing the color-coded strength on the primary display panel of the label.
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…