FDAHealthOctober 6, 2025
Heritage Pharmaceuticals Inc — 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
⚠️ CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- October 6, 2025
U.S. Nationwide.
What's affected?
- 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.
- UPC
- 0323155579017
- Lot code
- 18036908
Additional details
Lot#: 18036908, Exp. Date: 09/30/2026
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 6,979 bottles..
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