Class II · Moderate risk Ongoing
Finasteride NDC# 82187-1003-1 Container Description: The product…
Reason CGMP Deviations
FDA Drug Recalls
2,277 recalls · Class II, newest first
Class II · Moderate risk Ongoing
Alprostadil Container Description: Amber color bottle
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Bimatoprost NDC# 82187-1001-1 Container description: The…
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Morphine Sulfate Extended-Release Tablets
Reason Failed Dissolution Specifications
Class II · Moderate risk Ongoing
Silodosin Capsules
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 95.0% NMT 105%)
Class II · Moderate risk Ongoing
Ciprofloxacin Ophth Solution
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
Class II · Moderate risk Ongoing
Potassium Chloride Extended-Release Tablets
Reason Failed Dissolution Specifications.
Class II · Moderate risk Ongoing
Atomoxetine Capsules
Reason CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class II · Moderate risk Ongoing
Atomoxetine Capsules
Reason CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class II · Moderate risk Ongoing
Atomoxetine Capsules
Reason CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class II · Moderate risk Ongoing
Atomoxetine Capsules
Reason CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class II · Moderate risk Ongoing
Atomoxetine Capsules
Reason CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class II · Moderate risk Ongoing
Atomoxetine Capsules
Reason CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class II · Moderate risk Ongoing
Atomoxetine Capsules
Reason CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class II · Moderate risk Ongoing
Atomoxetine Capsules
Reason CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class II · Moderate risk Ongoing
Atomoxetine Capsules
Reason CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class II · Moderate risk Ongoing
Atomoxetine Capsules
Reason CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class II · Moderate risk Ongoing
Atomoxetine Capsules
Reason CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class II · Moderate risk Ongoing
Atomoxetine Capsules
Reason CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class II · Moderate risk Ongoing
Atomoxetine Capsules
Reason CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class II · Moderate risk Ongoing
Atomoxetine Capsules
Reason CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class II · Moderate risk Ongoing
HydrALAZINE Hydrochloride
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Ongoing
HydrALAZINE Hydrochloride
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Ongoing
Timolol Maleate Ophthalmic Solution USP
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.
Class II · Moderate risk Ongoing
Carvedilol Tablets
Reason CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit.