1,525 recalls · Class III, newest first
Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles. If the product is shaken or warmed the white particles goes into the solution.
Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles. If the product is shaken or warmed the white particles goes into the solution.
Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles. If the product is shaken or warmed the white particles goes into the solution.
Subpotent Drug: OOS (out of specification) assay result at the 12 month stability time point.
Does Not Meet Monograph: Budesonide may be slightly above or below the specification range.
Does Not Meet Monograph: Budesonide may be slightly above or below the specification range.
Subpotent Drug
Failed Dissolution Specifications; 8-hours for the 18-month stability testing point.
Crystallization: Recall is due to a non-characteristic gritty/sandy texture to the product which is likely due to some crystallization of the product.
Crystallization: Recall is due to a non-characteristic gritty/sandy texture to the product which is likely due to some crystallization of the product.
Failed Impurity/Degradation Specifications due to moisture ingress in individual bottles
Failed Impurity/Degradation Specifications due to moisture ingress in individual bottles
Defective Container: Product lacks tamper evident breakaway band on cap.
Impurities/Degradation Products: Out-of-specification results were obtained for a known impurities.
Impurities/Degradation Products: Out of Specification results found for impurity B, identified as the drug's metabolite.
Labeling: Label Error On Declared Strength; Some bottles of product were missing the color-coded strength on the primary display panel of the label.
Labeling: Label lacks warning or Rx legend; Certain information was inadvertently excluded from the product carton label.
Superpotent (Single Ingredient Drug): salicylic acid
Labeling: Not elsewhere classified: On 12/12/11, DEA published a final rule in the Federal Register making this product a schedule IV (C-IV)controlled substance. This product is being recalled because this controlled product was not relabeled with the required "C-IV" imprint on the label for products distributed after the 06/11/12 deadline.
Lack of Assurance of Sterility; potential that a low level of endotoxins may be present in the diluent vials.
Subpotent; 22 month stability timepoint
Subpotent; 12 month stability timepoint
Defective Container: Pump head detaching from the canister unit upon removal of the overcap.
Product Lacks Stability: These lots are being recalled due to the failure to meet the particle size distribution specification.
Product Lacks Stability: These lots are being recalled due to the failure to meet the particle size distribution specification.