Class II · Moderate risk
clomiPRAMINE Hydrochloride
cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.
FDA Drug Recalls
676 recalls · Class II, newest first
Class II · Moderate risk
clomiPRAMINE Hydrochloride
cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.
Class II · Moderate risk
Tylenol
Defective Container
Class II · Moderate risk
Opdualag (nivolumab and relatlimab-rmbw)
Lack of Assurance of Sterility.
Class II · Moderate risk
NIACIN Extended-Release Tablets
Failed Dissolution Specifications
Class II · Moderate risk
Acetaminophen 500mg Caffeine 65mg caplets
Labeling: Label Mix-up. This issue affects the outer box labeling only. The box incorrectly states the ingredients Acetaminophen 500mg and Caffeine 65mg. The inner pouch correctly states the ingredients are Aspirin (NSAID)*500mg and Caffeine 32.5mg.
Class II · Moderate risk
Prazosin Hydrochloride
Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit
Class II · Moderate risk
Prazosin Hydrochloride
Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit
Class II · Moderate risk
Prazosin Hydrochloride
Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit
Class II · Moderate risk
Tirzepatide Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Semaglutide Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Semaglutide Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Semaglutide Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Semaglutide Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Semaglutide Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Semaglutide Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Testosterone / Triamcinolone Acetonide Pellet
CGMP Deviations: Potential presence of metal particulate matter
Class II · Moderate risk
Testosterone / Triamcinolone Acetonide Pellet
CGMP Deviations: Potential presence of metal particulate matter
Class II · Moderate risk
Testosterone / Triamcinolone Acetonide 87.5MG/17.5MCG
CGMP Deviations: Potential presence of metal particulate matter
Class II · Moderate risk
Testosterone / Triamcinolone Acetonide
CGMP Deviations: Potential presence of metal particulate matter
Class II · Moderate risk
Testosterone / Triamcinolone Acetonide 50MG/10MCG
CGMP Deviations: Potential presence of metal particulate matter
Class II · Moderate risk
Testosterone / Triamcinolone Acetonide Pellet
CGMP Deviations: Potential presence of metal particulate matter
Class II · Moderate risk
Testosterone / Triamcinolone Acetonide 25MG/5MCG
CGMP Deviations: Potential presence of metal particulate matter
Class II · Moderate risk
Testosterone / Triamcinolone Acetonide
CGMP Deviations: Potential presence of metal particulate matter
Class II · Moderate risk
Testosterone Regular Release 200 MG
CGMP Deviations: Potential presence of metal particulate matter