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Clomipramine 75mg Capsules (Zydus) - Nitrosamine Risk (2025)

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 IIModerate

FDAOct 22, 2025Nationwide• Zydus Pharmaceuticals (USA) Inc

Clomipramine 25mg Capsules (Zydus) - Nitrosamine Risk (2025)

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 IIModerate

FDAOct 22, 2025Nationwide

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Clomipramine 75mg Capsules (Zydus) - Nitrosamine Risk (2025)

Clomipramine 25mg Capsules (Zydus) - Nitrosamine Risk (2025)

BioFire Respiratory Panel 2.1 (BioFire) – False Negative Risk (2025)

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MAHURKAR Catheter Tray (Mozarc) – Packaging Seal Integrity (2025)

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EZDilate Nephrostomy Catheter (Olympus) – Incorrect Balloon Size (2025)