676 recalls · Class II, newest first
Reason Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Reason Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Reason Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Reason Defective Container: broken or leaking bottles.
Reason Chemical Contamination
Reason Chemical Contamination
Reason Failed Impurities/Degradation Specifications
Reason Failed Impurities/Degradation Specifications
Reason Lack of assurance of sterility and cGMP deviations observed at the manufacturing site.
Reason Lack of Assurance of Sterility: There is a potential for leakage at the IV bottle port.
Reason CGMP Deviations
Reason CGMP Deviations
Reason CGMP Deviations
Reason CGMP Deviations
Reason CGMP Deviations
Reason CGMP Deviations
Reason Failed Dissolution Specifications
Reason Defective Container: Some packets may not be fully sealed, potentially allowing for loss of Ethanol from the product.
Reason Subpotent Drug: Out of Specification (OOS) result for De hydro Impurity (0.654%) for 18 M Stability sample and low assay 94.9% (specification of NLT…
Reason Defective Container: 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 Lack of Assurance of Sterility
Reason Failed Dissolution Specifications.
Reason CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Reason CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Reason CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.