Class II · Moderate risk
Pantoprazole Sodium Delayed Release Tablets USP
cGMP Deviations: Oral products were not manufactured in accordance with Good Manufacturing Practices.
FDA Drug Recalls
1,724 recalls · Class II, newest first
Class II · Moderate risk
Benjamins Infants Gripe Mixture
CGMP Deviations: this product is being recalled because an FDA inspection revealed that it was not manufactured under current good manufacturing practices.
Class II · Moderate risk
Medi-bolic Booster Injectable
CGMP Deviations: Pharmaceutical for injection was not manufactured according to Good Manufacturing Procedures.
Class II · Moderate risk
ABILIFY (aripiprazole)
CGMP Deviations: A drum of Abilify 30 mg Tablets rejected during the compression stage was not segregated from the other portion of the lot and was inadvertently shipped, packaged and distributed.
Class II · Moderate risk
All Non-Sterile Products manufactured by Ameridose LLC
GMP deficiencies
Class II · Moderate risk
All Non Sterile Products manufactured by NECC
GMP Deviations
Class II · Moderate risk
Orajel Kids My Way! Anticavity Fluoride
CGMP Deviations: Product was made with an incorrect ingredient, Laureth-9 was mistakenly substituted for PEG.
Class II · Moderate risk
Levothroid
cGMP Deviations; does not meet in process specification requirements
Class II · Moderate risk
Thyro-Tab 0.300 mg.
cGMP Deviations; does not meet in process specification requirements
Class II · Moderate risk
Levothroid
cGMP Deviations; does not meet in process specification requirements
Class II · Moderate risk
Thyro-Tab 0.137 mg.
cGMP Deviations; does not meet in process specification requirements
Class II · Moderate risk
Levothroid
cGMP Deviations; does not meet in process specification requirements
Class II · Moderate risk
Thyro-Tab 0.125 mg.
cGMP Deviations; does not meet in process specification requirements
Class II · Moderate risk
Levothroid
cGMP Deviations; does not meet in process specification requirements
Class II · Moderate risk
Thyro-Tab 0.112 mg.
cGMP Deviations; does not meet in process specification requirements
Class II · Moderate risk
Levothroid
cGMP Deviations; does not meet in process specification requirements
Class II · Moderate risk
Thyro-Tab 0.088 mg.
cGMP Deviations; does not meet in process specification requirements
Class II · Moderate risk
Levothroid
cGMP Deviations; does not meet in process specification requirements
Class II · Moderate risk
Thyro-Tab 0.050 mg.
cGMP Deviations; does not meet in process specification requirements
Class II · Moderate risk
Oxygen
CGMP Deviations; no identity or purity testing on incoming oxygen gas, and lack of documentation
Class II · Moderate risk
Cardiogen-82
GMP deviation; Sr-82 levels exceeded alert limit specification
Class II · Moderate risk
Zemplar (paricalcitol)
CGMP Deviations: There is potential that Abbott's third party manufacturer, Hospira, may have applied a foreign (incorrect) stopper to vials in a specific lot of Zemplar Injection.
Class II · Moderate risk
Eloxatin (OXALIplatin injection)
CGMP Deviations: Eloxatin was manufactured by Ben Venue Laboratories, a contract manufacturer, which was recently inspected by the agency and revealed significant issues in Good Manufacturing Practices.
Class II · Moderate risk
Eloxatin (OXALIplatin injection)
CGMP Deviations: Eloxatin was manufactured by Ben Venue Laboratories, a contract manufacturer, which was recently inspected by the agency and revealed significant issues in Good Manufacturing Practices.