FDA Drug Class II — Moderate

Desipramine Hydrochloride Tablets, USP, 150 mg, 50 count bottle (NDC 23155-583-25), Rx only, Manufactured by: USV Private Limited, Daman, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816.

Hazard

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

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Products

Desipramine Hydrochloride Tablets, USP, 150 mg, 50 count bottle (NDC 23155-583-25), Rx only, Manufactured by: USV Private Limited, Daman, India, Manufactured for: Avet Pharmaceuticals Inc., East Bruns
Brand
Heritage Pharmaceuticals Inc
UPC
Lot#: 18035739, Exp. Date: 11/30/2025

Units Affected

3,750 bottles.

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