14,450 recalls · Class II, newest first
Reason Incorrect/Undeclared Excipients: The inactive ingredients labeled on the product boxes and tubes are listed as "mineral oil , petrolatum ". The inactive ingredients in the actual product are polyethylene glycol 400 , polyethylene glycol 4000.
Reason Lack of Assurance of Sterility
Reason Failed Dissolution Specifications
Reason Microbial Contamination of Non-Sterile Product
Reason Subpotent Drug
Reason Microbial contamination of non-sterile Products -
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 Subpotent Drug- An out of specification ( OOS ) result observed in assay test during 18-month long term stability study.
Reason Lack of Assurance of Sterility
Reason Defective Container: patients are unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.
Reason Failed Impurities/Degradation Specifications: Product failed impurity specifications at the 18-month stability testing.
Reason Failed Impurities/Degradation Specifications - at 18-month Stability testing
Reason Superpotent Drug
Reason Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.
Reason Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.
Reason Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.
Reason CGMP Deviations: sterile water not used for production
Reason CGMP Deviations: sterile water not used for production
Reason Lack of Assurance of Sterility