FDARecalled Nov 12, 2025 · #D-0154-2026
clomiPRAMINE Hydrochloride, Capsules, USP, 75 mg, packaged in a) 30-count bottles (NDC 16714-851-01), b) 90-count bottles (NDC 16714-851-02), c) 100 capsules, NDC 16714-851-03 Rx only, Manufactured...
Hazard
Class II — temporary health risk
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cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit. Classification: Class II Distribution: Nationwide in the US
Product details
- Product
- clomiPRAMINE Hydrochloride, Capsules, USP, 75 mg, packaged in a) 30-count bottles (NDC 16714-851-01), b) 90-count bottles (NDC 16714-851-02), c) 100 capsules, NDC 16714-851-03 Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India.
- Type
- Drugs
- Manufacturer
- Zydus Pharmaceuticals (USA) Inc
- Model numbers
- E403069, E406504, E309177, E400262, E404200, E403070, E406505, E407631, E400263, E404202, E403071, E407632, E405848, E400264, E404201
- UPCs
- —