Class II · Moderate risk Terminated
Pt-141
Reason Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
FDA Drug Recalls
17,898 recalls, newest first
Class II · Moderate risk Terminated
Melanotan II 1 mg/mL
Reason Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
Class II · Moderate risk Terminated
LL-37 2 mg/mL
Reason Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
Class II · Moderate risk Terminated
Ipamorelin Acetate/Sermorelin Acetate
Reason Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
Class II · Moderate risk Terminated
BPC-157 2 mg/mL
Reason Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
Class II · Moderate risk Terminated
Ara-290
Reason Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
Class III · Low risk Terminated
Cyanocobalamin Injection
Reason Subpotent Drug: Out of Specification results for Assay
Class II · Moderate risk Terminated
BEAK & SKIFF SANITIZER Alcohol Antiseptic 80%
Reason CGMP Deviations: FDA analysis found product to contain acetaldehyde above specification limits.
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.
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