FDA recall D-0754-2021

Product

Carvedilol 25 mg, 180-count bottle, Rx only, Manufactured by Zydus Pharm, Pennington, NJ 08534, NDC 68382-0095-05, Repackaged by RemedyRepack Inc., Indiana, PA 15701, NDC 70518-1826-01

Reason for recall

A 500 count bottle of Carvedilol 25 mg tablets contained two Paroxetine Tablets, 40 mg. Product was repackaged into 180 count bottles.

Distribution

Product was distributed to two medical facilities in VA and FL.

Key facts

Status

Terminated

Initiation date

2021-08-17

Report date

2021-09-01

Termination date

2022-03-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

Indiana, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0754-2021