Recalls / Class II
Class IID-0753-2021
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
- Brand name
- Carvedilol
- Generic name
- Carvedilol
- Active ingredient
- Carvedilol
- Route
- Oral
- NDCs
- 68382-092, 68382-093, 68382-094, 68382-095
- FDA application
- ANDA077614
- Affected lot / code info
- Z006279, exp 12/31/2022
Why it was recalled
Presence of Foreign Tablets/Capsules; report of two Paroxetine tablets were found in the bottle
Recalling firm
- Firm
- Zydus Pharmaceuticals (USA) Inc
- Manufacturer
- Zydus Pharmaceuticals USA Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 73 Route 31 N, N/A, Pennington, New Jersey 08534-3601
Distribution
- Quantity
- 2880 bottles
- Distribution pattern
- Nationwide in the US
Timeline
- Recall initiated
- 2021-08-13
- FDA classified
- 2021-08-19
- Posted by FDA
- 2021-08-25
- Terminated
- 2023-04-03
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0753-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.