Drug recall D-0107-2026
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 for recall
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Lots and codes
Lot#: 18036908, Exp. Date: 09/30/2026
Recall details
- Recalling firm
- Heritage Pharmaceuticals Inc, East Brunswick, NJ
- Quantity
- 6,979 bottles.
- Distribution
- U.S. Nationwide.
- Type
- Voluntary: Firm initiated
- Recall initiated
- October 6, 2025
Related products
- Desipramine Hydrochloride – drug information
- NDC 23155-578 Desipramine Hydrochloride · Desipramine Hydrochloride 10 mg/1 · Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
- NDC 23155-579 Desipramine Hydrochloride · Desipramine Hydrochloride 25 mg/1 · Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
- NDC 23155-581 Desipramine Hydrochloride · Desipramine Hydrochloride 75 mg/1 · Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.