FDA-Drug2025-11-05Class II
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.
Heritage Pharmaceuticals Inc
Hazard
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Sold states
U.S. Nationwide.
Affected count
8,754 bottles.
Manufactured in
1 Tower Center Blvd Ste 1700, N/A, East Brunswick, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0108-2026Don't want to check this manually?
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