Class II · Moderate risk Terminated
HAND SANITIZER SAY GOODBYE TO GERMS Alcohol Antiseptic 80%…
Reason CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.
FDA Drug Recalls
14,801 recalls, newest first
Class II · Moderate risk Terminated
NAD+ Nicotinamide Adenine Dinucleotide Lyophilized powder for reconstitution
Reason Failed Reconstitution time
Class II · Moderate risk Terminated
Sincalide. Lyophilized powder for reconstitution. 5 mcg per Multi-Dose vial
Reason CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
Class II · Moderate risk Terminated
Hydroxocobalamin B12
Reason CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
Class II · Moderate risk Terminated
Ultratest
Reason CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
Class II · Moderate risk Terminated
Testosterone Cypionate 200 mg/mL
Reason CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
Class II · Moderate risk Terminated
Testosterone Cypionate 200 mg/mL
Reason CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
Class II · Moderate risk Terminated
Phenylephrine 1 mg/mL
Reason CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
Class II · Moderate risk Terminated
Formula F2
Reason CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
Class II · Moderate risk Terminated
T-50
Reason CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
Class II · Moderate risk Terminated
Pge-3
Reason CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
Class II · Moderate risk Terminated
Pge-2
Reason CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
Class II · Moderate risk Terminated
Pge-1
Reason CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
Class II · Moderate risk Terminated
FA, Papaverine 20 mg/mL . Phentolamine 2 mg/mL . Alprostadil 20…
Reason CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
Class II · Moderate risk Terminated
Bimix-3
Reason CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
Class II · Moderate risk Terminated
Re-2
Reason CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
Class II · Moderate risk Terminated
Re-1
Reason CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
Class II · Moderate risk Terminated
Qm-4
Reason CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
Class II · Moderate risk Terminated
Qm-3
Reason CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
Class II · Moderate risk Terminated
St-2
Reason CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
Class II · Moderate risk Terminated
St-1
Reason CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
Class II · Moderate risk Terminated
Sb-6
Reason CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
Class II · Moderate risk Terminated
Sb-5
Reason CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
Class II · Moderate risk Terminated
Sb-4
Reason CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
Class II · Moderate risk Terminated
T-101
Reason CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated