Carvedilol Tablets, USP 25 mg, 500 Tablets bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd., India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 0853, NDC 68382-095-05
FDA recall notice · announced August 25, 2021 · Zydus Pharmaceuticals (usa)
Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.
The product
Carvedilol Tablets, USP 25 mg, 500 Tablets bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd., India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 0853, NDC 68382-095-05
Reason for recall
Presence of Foreign Tablets/Capsules; report of two Paroxetine tablets were found in the bottle
Notes
Distribution: Nationwide in the US
Lot/code information: Z006279, exp 12/31/2022
Quantity: 2880 bottles
Status: Terminated
Products in this recall event:
- Carvedilol Tablets, USP 25 mg, 500 Tablets bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd., India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 0853, NDC 68382-095-05 (D-0753-2021)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.