Class II · Moderate risk Terminated
0.9% Sodium Chloride Irrigation USP 5000 mL bags
Reason Lack of Assurance of Sterility: Product has the potential to leak.
FDA Drug Recalls
14,450 recalls · Class II, newest first
Class II · Moderate risk Terminated
Myorisan
Reason Unit Dose Mispackaging: Customer complaint that a carton labeled as Myorisan 20 mg Capsules, USP erroneously contained one 10-count blister card of the 40 mg product in addition to two 10-count blister cards of the 20 mg product.
Class II · Moderate risk Terminated
Yeast Arrest
Reason cGMP violations
Class II · Moderate risk Terminated
AVKARE Ranitidine Tablets
Reason CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Class II · Moderate risk Terminated
AVKARE Ranitidine Tablets
Reason CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Class II · Moderate risk Terminated
Ranitidine Oral Solution
Reason CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API.
Class II · Moderate risk Terminated
Fluphenazine Decanoate Injection USP 125mg/5mL
Reason Discoloration; Hazy solution found in one vial instead of a clear solution.
Class II · Moderate risk Terminated
fentaNYL 550 mcg/55 mL
Reason Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Class II · Moderate risk Terminated
fentaNYL 1000 mcg/100 mL
Reason Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Class II · Moderate risk Terminated
fentaNYL 1500 mcg/30 mL
Reason Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Class II · Moderate risk Terminated
fentaNYL 2500 mcg/50 mL
Reason Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Class II · Moderate risk Terminated
fentaNYL 800 mcg/200 mL
Reason Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Class II · Moderate risk Terminated
fentaNYL 1250 mcg/250 mL
Reason Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Class II · Moderate risk Terminated
fentaNYL 1000 mcg/20 mL
Reason Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Class II · Moderate risk Terminated
fentaNYL 200 mcg/100 mL
Reason Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Class II · Moderate risk Terminated
fentaNYL 400 mcg/200 mL
Reason Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Class II · Moderate risk Terminated
fentaNYL 2000 mcg/100 mL
Reason Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Class II · Moderate risk Terminated
fentaNYL 400 mcg/200 mL
Reason Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Class II · Moderate risk Terminated
fentaNYL 200 mcg/100 mL
Reason Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Class II · Moderate risk Terminated
fentaNYL 250 mcg/5 mL
Reason Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Class II · Moderate risk Terminated
fentaNYL 200 mcg/100 mL
Reason Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Class II · Moderate risk Terminated
fentaNYL 2750 mcg/55 mL
Reason Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Class II · Moderate risk Terminated
fentaNYL 200 mcg/100 mL
Reason Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Class II · Moderate risk Terminated
fentaNYL 100 mcg/2 mL
Reason Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Class II · Moderate risk Terminated
fentaNYL 1000 mcg/100 mL
Reason Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules