Drug product

clomiPRAMINE Hydrochloride, Capsules, USP, 25 mg, packaged in a) 30-count bottles (NDC 16714-849-01), b) 90-count bottles (NDC 16714-849-02), c) 100-count bottles (NDC 16714-849-03), Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India

D-0152-2026

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-0152-2026

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 # E408871, Exp Date: 10/2026; Lot # E405282, Exp Date: 06/2026; Lot # E400386, Exp Date: 12/2025 b) Lot # E408872, Exp Date: 10/2026; Lot # E405280, Exp Date: 06/2026 c) Lot # E408873, Exp Date: 10/2026; Lot # E405281, Exp Date: 06/2026; Lot # E400387, Exp Date: 12/2025

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