Recalls / Class III
Class IIID-0263-2022
Product
Carvedilol Tablets, USP, 6.25 mg, 500 Tablets bottle, Rx Only, Distributed by: Aurobindo Pharma USA Inc., 279 Princeton-Hightstown Road, East Windsor, NJ, 08520, Made in India, NDC 65862-143-05
- Brand name
- Carvedilol
- Generic name
- Carvedilol
- Active ingredient
- Carvedilol
- Route
- Oral
- NDCs
- 65862-142, 65862-143, 65862-144, 65862-145
- FDA application
- ANDA078332
- Affected lot / code info
- Batch QG0619030-A, exp 11/2022
Why it was recalled
Failed Impurities/Degradation Specifications
Recalling firm
- Firm
- Aurobindo Pharma USA Inc.
- Manufacturer
- Aurobindo Pharma Limited
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 279 Princeton Hightstown Rd, East Windsor, New Jersey 08520-1401
Distribution
- Quantity
- 7296 containers
- Distribution pattern
- Nationwide in the US
Timeline
- Recall initiated
- 2021-11-15
- FDA classified
- 2021-12-01
- Posted by FDA
- 2021-12-01
- Terminated
- 2023-08-23
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0263-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.