FDA recall D-0495-2023

Product

Rosuvastatin 5mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-3519-00.

Reason for recall

cGMP Deviations

Distribution

RemedyRepack distributed product to consignees nationwide within the United States

Key facts

Status

Terminated

Initiation date

2023-03-20

Report date

2023-04-12

Termination date

2023-10-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Indiana, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0495-2023