Class II · Moderate risk Ongoing
Atomoxetine Capsules
Reason CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
FDA Drug Recalls
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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 I · High risk Ongoing
SinuCleanse Soft Tip NETI POT Nasal Wash System
Reason Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus
Class I · High risk Ongoing
SinuCleanse Premixed SALINE PACKETS
Reason Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus
Class I · High risk Ongoing
SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System
Reason Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus
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 Terminated
Carvedilol 25 mg Tablet
Reason CGMP deviations: presence of N-Nitroso Carvedilol Impurity-1 (NNC 1), above the FDA recommended acceptable intake limit.
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.
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.
Class I · High risk Ongoing
Phenylephrine HCl Injection
Reason Presence of Particulate Matter.
Class II · Moderate risk Ongoing
Lorazepam Tablets
Reason Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.
Class II · Moderate risk Ongoing
Lorazepam Tablets
Reason Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.