Drug 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
D-0263-2022
Product summary
- Event
- Event 89045
- Status
- Terminated
- Classification
- Class III
- Quantity
- 7296 containers
- Official record key
drug-enforcement:D-0263-2022
Official wording
Reason: Failed Impurities/Degradation Specifications
Code information: Batch QG0619030-A, exp 11/2022
Distribution pattern: Nationwide in the US
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications