Drug product

clomiPRAMINE Hydrochloride, Capsules, USP, 50 mg, packaged in a) 30-count bottles (NDC 16714-850-01), b) 90-count bottles (NDC 16714-850-02), c) 100-count bottles (NDC 16714-850-03), Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India

D-0153-2026

October 22, 2025

Class II

Product summary

Firm: Zydus Pharmaceuticals (USA) Inc
Event: Event 97856
Status: Ongoing
Classification: Class II
Quantity: N/A
Official record key: drug-enforcement:D-0153-2026

Official wording

Reason: cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.

Code information: a) Lot # E410157, Exp Date: 12/2026; Lot # E407176, Exp Date: 08/2026; Lot # E405845, Exp Date: 06/2026; Lot # E400943, Exp Date: 01/2026 b)Lot # E410156, Exp Date: 12/2026; Lot # E400942, Exp Date: 01/2026 c) Lot # E410158, Exp Date: 12/2026; Lot # E407128, Exp Date: 08/2026; Lot # E405846, Exp Date: 06/2026; Lot # E400944, Exp Date: 01/2026

Distribution pattern: Nationwide in the US

Derived failure modes

Foreign material or chemical contamination
reason.foreign_material_chemical_contamination · v1.0.0

Nitrosamine Drug Substance-Related Impurities
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0

cGMP deviations
Potency or specification failure
reason.potency_specification_failure · v1.0.0

Out of Specification