FDA Drug Class II — Moderate

Desipramine Hydrochloride Tablets, USP, 75 mg, 100 count bottle (NDC 23155-581-01), 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, 75 mg, 100 count bottle (NDC 23155-581-01), Rx only, Manufactured by: USV Private Limited, Daman, India, Manufactured for: Avet Pharmaceuticals Inc., East Bruns
Brand
Heritage Pharmaceuticals Inc
UPC
Lot#: 18036662, Exp. Date: 07/31/2026 Lot#: 18037649, Exp. Date: 03/31/2027

Units Affected

2,418 bottles.

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