FDA Drug Class II — Moderate

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.

Hazard

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

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Products

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 Brun
Brand
Heritage Pharmaceuticals Inc
UPC
Lot#: 18035574, Exp. Date 10/31/2025 Lot#: 18036758, Exp. Date 08/31/2026

Units Affected

5,882 bottles.

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