FDA recall D-0501-2023

Product

Rosuvastatin 10mg tablets, packaged in a) 30-count bottles (NDC 70518-0375-03 and 70518-0375-01) and b) 90-count bottles (NDC 70518-0375-00), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701.

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-0501-2023