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

FDA recall notice · announced December 1, 2021 · Aurobindo Pharma

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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

Reason for recall

Failed Impurities/Degradation Specifications

Notes

Distribution: Nationwide in the US
Lot/code information: Batch QG0619030-A, exp 11/2022
Quantity: 7296 containers
Status: Terminated
Products in this recall event:
- 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)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.