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Recall Observatory FDA recall evidence

Drug product

Desipramine Hydrochloride Tablets, USP, 100 mg, 100 count bottle (NDC 23155-582-01), Rx only, Manufactured by: USV Private Limited, Daman, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816.

D-0111-2026

October 06, 2025

Class II

Product summary

Firm
Heritage Pharmaceuticals Inc
Event
Event 97770
Status
Ongoing
Classification
Class II
Quantity
5,882 bottles.
Official record key
drug-enforcement:D-0111-2026

Official wording

Reason: CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.

Code information: Lot#: 18035574, Exp. Date 10/31/2025 Lot#: 18036758, Exp. Date 08/31/2026

Distribution pattern: U.S. Nationwide.

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    N-Nitroso Desipramine impurity
  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations