Class II · Moderate risk
Silodosin Capsules
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%)
FDA Drug Recalls
18,003 recalls, newest first
Class II · Moderate risk
Ciprofloxacin Ophth Solution
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 I · High risk
Fentanyl Transdermal System CII
Defective delivery system - patches could be multi-stacked, adhered one on top of the other, in a single product pouch.
Class II · Moderate risk
fentaNYL Citrate In Sodium Chloride 1600mcg/100mL
Lack of Assurance of Sterility
Class II · Moderate risk
Potassium Chloride Extended-Release Tablets
Failed Dissolution Specifications.
Class II · Moderate risk
Atomoxetine Capsules
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class II · Moderate risk
Atomoxetine Capsules
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class II · Moderate risk
Atomoxetine Capsules
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class II · Moderate risk
Atomoxetine Capsules
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class II · Moderate risk
Atomoxetine Capsules
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class II · Moderate risk
Atomoxetine Capsules
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class II · Moderate risk
Atomoxetine Capsules
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class II · Moderate risk
Atomoxetine Capsules
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class II · Moderate risk
Atomoxetine Capsules
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class II · Moderate risk
Atomoxetine Capsules
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class II · Moderate risk
Atomoxetine Capsules
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class II · Moderate risk
Atomoxetine Capsules
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class II · Moderate risk
Atomoxetine Capsules
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class II · Moderate risk
Atomoxetine Capsules
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class I · High risk
SinuCleanse Soft Tip NETI POT Nasal Wash System
Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus
Class I · High risk
SinuCleanse Premixed SALINE PACKETS
Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus
Class I · High risk
SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System
Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus
Class II · Moderate risk
HydrALAZINE Hydrochloride
Failed Impurities/Degradation Specifications
Class II · Moderate risk
HydrALAZINE Hydrochloride
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Carvedilol 25 mg Tablet
CGMP deviations: presence of N-Nitroso Carvedilol Impurity-1 (NNC 1), above the FDA recommended acceptable intake limit.