Class IIDULOXETINE2026-06-10
CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit.
Recalling firm: Asclemed USA Inc.
Class IICINACALCET2025-12-17
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Recalling firm: Cipla USA, Inc.
Class IICINACALCET2025-12-17
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Recalling firm: Cipla USA, Inc.
Class IICINACALCET2025-12-17
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Recalling firm: Cipla USA, Inc.
Class IICLOMIPRAMINE HYDROCHLORIDE2025-11-12
cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit
Recalling firm: Zydus Pharmaceuticals (USA) Inc
Class IICLOMIPRAMINE HYDROCHLORIDE2025-11-12
cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit
Recalling firm: Zydus Pharmaceuticals (USA) Inc
Class IICLOMIPRAMINE HYDROCHLORIDE2025-11-12
cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit
Recalling firm: Zydus Pharmaceuticals (USA) Inc