Drug recall
Carvedilol Tablets, USP 25 mg, 500 Tablets bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd., India…
FDA recall event 88482 · Class II · Zydus Pharmaceuticals (USA) Inc
Key facts
| Event ID | 88482 |
|---|---|
| Recall numbers | D-0753-2021 |
| Recalling firm | Zydus Pharmaceuticals (USA) Inc |
| Product type | Drugs |
| Products | 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 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Presence of Foreign Tablets/Capsules; report of two Paroxetine tablets were found in the bottle |
| Initiation date | Aug 13, 2021 |
| Report date | Aug 25, 2021 |
| Termination date | Apr 3, 2023 |
| City | Pennington |
| State | NJ |
| Country | United States |
| FEI number | 3008444937 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: