Class II · Moderate risk Completed
Zonisamide Capsules
Reason cGMP deviations
FDA Drug Recalls
14,450 recalls · Class II, newest first
Class II · Moderate risk Completed
Zonisamide Capsules
Reason cGMP deviations
Class II · Moderate risk Completed
Zonisamide Capsules USP
Reason cGMP deviations
Class II · Moderate risk Terminated
Accupril
Reason CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits.
Class II · Moderate risk Terminated
Accupril
Reason CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits.
Class II · Moderate risk Terminated
Accupril
Reason CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits.
Class II · Moderate risk Ongoing
Erythromycin Topical Gel USP
Reason CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.
Class II · Moderate risk Ongoing
Betamethasone Dipropionate Ointment USP
Reason CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.
Class II · Moderate risk Ongoing
Lidocaine Prilocaine Cream USP
Reason CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.
Class II · Moderate risk Ongoing
Lidocaine Hydrochloride Topical Solution USP 4%
Reason CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.
Class II · Moderate risk Ongoing
Halobetasol Propionate Ointment 0.05% Net Wt.
Reason CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.
Class II · Moderate risk Terminated
Torco Racing Fuels Hand Sanitizer
Reason CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.
Class II · Moderate risk Terminated
Lansoprazole Delayed-Release Orally Disintegrating Tablets
Reason Failed Dissolution Specifications
Class II · Moderate risk Terminated
Losartan Potassium & Hydrochlorothiazide Tablets
Reason CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class II · Moderate risk Terminated
Losartan Potassium & Hydrochlorothiazide Tablets
Reason CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class II · Moderate risk Terminated
Losartan Potassium & Hydrochlorothiazide Tablets
Reason CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class II · Moderate risk Terminated
Losartan Potassium Tablets
Reason CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class II · Moderate risk Terminated
Losartan Potassium Tablets
Reason CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class II · Moderate risk Terminated
Losartan Potassium Tablets
Reason CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class II · Moderate risk Terminated
Lidocaine 2.5% and Prilocaine 2.5% Cream
Reason cGMP Deviations
Class II · Moderate risk Terminated
Paracentesis/Thoracentises Tray
Reason cGMP deviations: Temperature abuse
Class II · Moderate risk Terminated
Biopsy and Aspiration Tray Bone Marrow Illinois 11GX4
Reason cGMP deviations: Temperature abuse
Class II · Moderate risk Terminated
Intralipid
Reason cGMP deviations: Temperature abuse
Class II · Moderate risk Terminated
Intralipid
Reason cGMP deviations: Temperature abuse
Class II · Moderate risk Terminated
Cefazolin for injection USP
Reason cGMP deviations: Temperature abuse