FDA recall D-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

Reason for recall

Presence of Foreign Tablets/Capsules; report of two Paroxetine tablets were found in the bottle

Distribution

Nationwide in the US

Key facts

Status

Terminated

Initiation date

2021-08-13

Report date

2021-08-25

Termination date

2023-04-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

Pennington, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0753-2021