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Heritage Pharmaceuticals Inc: Desipramine Hydrochloride Tablets, USP, 10 mg, 100 - count bottle (NDC 23155-578-01), Rx only, Manufactured by: USV Private Limited, Daman,

DrugsSource: FDA (drug) · Date: 2025-11-05

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The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.

Company / brand
Heritage Pharmaceuticals Inc
Product
Desipramine Hydrochloride Tablets, USP, 10 mg, 100 - count bottle (NDC 23155-578-01), Rx only, Manufactured by: USV Private Limited, Daman, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816.
Reason / hazard
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Classification
Class II
Status
Ongoing
Distribution / sold at
U.S. Nationwide.
Recall initiated
2025-10-06
Code info
Lot#: 18036908, Exp. Date: 09/30/2026
Product quantity
6,979 bottles.
Voluntary mandated
Voluntary: Firm initiated
City
East Brunswick
State
NJ
Country
United States
Event id
97770
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