2,277 recalls · Class II, newest first
Reason Incorrect product concentration on the overwrap label: The overwrap label incorrectly identified the product strength as 4 mg / 250 mL; however, the primary bag label correctly identified the product strength as 8 mg / 250 mL.
Reason Sub-potent drug: failure to maintain potency through the duration of the labeled expiration/beyond-use date.
Reason Failed Impurities/Degradation Specification: Out of specification for organic impurities
Reason CGMP Deviations: products may not conform to the labeled specifications.
Reason CGMP Deviations: products may not conform to the labeled specifications.
Reason Subpotent Drug
Reason Superpotent Drug: Assay from the 3-month and 6-month stability intervals exceeded the upper specification limit.
Reason Labeling: Not Elsewhere Classified; Product labeling contains the claim of 'Paraben Free' while the product does in fact contain parabens as part of the formulation/ ingredient list.
Reason Failed Dissolution Specifications
Reason Presence of Foreign Tablet/Capsule: A stray Rasagiline Mesylate 1 mg tablet was discovered in an unopened bottle of Ibuprofen and Famotidine.
Reason Presence of Foreign Tablets/Capsules
Reason Lack of Sterility Assurance
Reason CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products.
Reason CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products.
Reason CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products.
Reason CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products.
Reason MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria.
Reason MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria.
Reason MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria.
Reason MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria.
Reason MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria.
Reason CGMP Deviations: Stability data does not support expiry date.
Reason CGMP Deviations: Inadequate line clearance which may result in a potential comingling of product.
Reason Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
Reason Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.