721 recalls, newest first
Labeling: Label Error on Declared Strength. Cases labeled POTASSIUM CHLORIDE 20 mEq, may contain flexible containers with overwrap mislabeled as 10 mEq. The correct dosage strength of 20 mEq is printed on the labeling affixed to the product flexible container.
Failed Impurities/Degradation Specifications
Failed Impurities/Degradation Specifications
Lack of assurance of sterility and cGMP deviations observed at the manufacturing site.
CGMP Deviations
CGMP Deviations
CGMP Deviations
Failed Dissolution Specifications
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 95.0% NMT 105%)
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
Defective delivery system - patches could be multi-stacked, adhered one on top of the other, in a single product pouch.
Failed Dissolution Specifications.
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.