Class II · Moderate risk
Pertussinum
cGMP deviations
FDA Drug Recalls
1,724 recalls · Class II, newest first
Class II · Moderate risk
Morbillinum
cGMP deviations
Class II · Moderate risk
Medorrhinum
cGMP deviations
Class II · Moderate risk
Influenzinum
cGMP deviations
Class II · Moderate risk
Diphtherinum
cGMP deviations
Class II · Moderate risk
Colibacillinum
cGMP deviations
Class II · Moderate risk
Candida Parapsilosis
cGMP deviations
Class II · Moderate risk
Candida Albicans
cGMP deviations
Class II · Moderate risk
Bacillinum Pulmo
cGMP deviations
Class II · Moderate risk
Anthracinum
cGMP deviations
Class II · Moderate risk
Alcohol Antiseptic 80%
CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.
Class II · Moderate risk
Vancomycin HCl 1.5 g in 0.9% Sodium Chloride
CGMP Deviations
Class II · Moderate risk
Class II · Moderate risk
Norepinephrine 8mg in 0.9% Sodium Chloride 250 mL bag
CGMP Deviations
Class II · Moderate risk
Zonisamide Capsules
cGMP deviations
Class II · Moderate risk
Zonisamide Capsules
cGMP deviations
Class II · Moderate risk
Zonisamide Capsules USP
cGMP deviations
Class II · Moderate risk
Torco Racing Fuels Hand Sanitizer
CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.
Class II · Moderate risk
Lidocaine 2.5% and Prilocaine 2.5% Cream
cGMP Deviations
Class II · Moderate risk
Pantoprazole Sodium Delayed-Release Tablets
CGMP deviations: tablets cracking
Class II · Moderate risk
Kill 'Dat Sanitizing Products Hand Sanitizer
CGMP Deviations: FDA analysis found product to contain acetaldehyde above specification limits.
Class II · Moderate risk
HAND SANITIZER SAY GOODBYE TO GERMS Alcohol Antiseptic 80% Topical Non-Sterile Solution
CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.
Class II · Moderate risk
Sincalide. Lyophilized powder for reconstitution. 5 mcg per Multi-Dose vial
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
Hydroxocobalamin B12
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
Ultratest
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated