1,122 recalls, newest first
Reason CGMP Deviations: Products not manufactured under current good manufacturing practices.
Reason CGMP Deviations: Products not manufactured under current good manufacturing practices.
Reason CGMP Deviations: Products not manufactured under current good manufacturing practices.
Reason CGMP Deviations: Products not manufactured under current good manufacturing practices.
Reason Labeling: Incorrect or Missing Lot and/or Exp Date: vials were labeled with the incorrect lot number and expiration date
Reason Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with sildenafil an ingredient found in a FDA approved product for…
Reason Failed dissolution specifications - results obtained were below spec average.
Reason CGMP Deviations
Reason CGMP Deviations
Reason CGMP Deviations
Reason CGMP Deviations
Reason CGMP Deviations
Reason Labeling: Not Elsewhere Classified - the description, warnings, storage information and instructions for use are either missing or partially printed.
Reason Failed Impurities/Degradation Specifications
Reason cGMP deviations: Batch was released prior to approval.
Reason cGMP deviations: Batch was released prior to approval.
Reason CGMP deviation: product released prior to supplier approval.
Reason cGMP deviations: due to shipment of rejected units.
Reason Failed Impurities/Degradation Specifications: Out-of-specification results observed for the organic impurities test at 6 months, RT Stability.
Reason Out of Specification result observed in content uniformity testing
Reason Lack of assurance of sterility: Lack of validation data for sanitization cycles
Reason Lack of assurance of sterility: Lack of validation data for sanitization cycles
Reason Lack of assurance of sterility: Lack of validation data for sanitization cycles
Reason Lack of assurance of sterility: Lack of validation data for sanitization cycles
Reason Lack of assurance of sterility: Lack of validation data for sanitization cycles