359 recalls, newest first
Reason The filter included in the carton has an expiration date that has expired prior to the expiration date of the actual product lot.
Reason Presence of Particulate Matter.
Reason CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Reason CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Reason Lack of Assurance of Sterility: Firm did not perform process validation.
Reason Lack of Assurance of Sterility: Firm did not perform process validation.
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Failed Impurities/Degradation Specifications: Out of specification for organic impurities
Reason Failed Impurities/Degradation Specifications: Out of specification for organic impurities
Reason Failed Dissolution Specifications
Reason Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.
Reason Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.
Reason Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
Reason Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
Reason Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
Reason Stability testing failures for one or two of the four active pharmaceutical ingredients among the finished drug products, i.e., Phenylephrine HCL…