D-0108-2026 Class II Ongoing
FDA drug recall D-0108-2026 was initiated by Heritage Pharmaceuticals Inc on October 6, 2025 and is designated Class II. Reason for recall: CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level. The recall status is ongoing. Affected quantity: 8,754 bottles..
Recall Details
- Product Type
- Drugs
- Report Date
- November 5, 2025
- Initiation Date
- October 6, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8,754 bottles.
Product Description
Desipramine Hydrochloride Tablets, USP, 25 mg, 100 count bottle (NDC 23155-579-01), 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.
Distribution Pattern
U.S. Nationwide.
Code Information
Lot#: 18035876, Exp Date: 12/31/2025 Lot#: 18036909, Exp Date: 09/30/2026