FDA recall D-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

Reason for recall

Failed Impurities/Degradation Specifications

Distribution

Nationwide in the US

Key facts

Status

Terminated

Initiation date

2021-11-15

Report date

2021-12-01

Termination date

2023-08-23

Voluntary/Mandated

Voluntary: Firm initiated

Location

East Windsor, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0263-2022