FDA recall D-0496-2023

RemedyRepack Inc. · Class II · drug

Product

Simvastatin 10 mg tablets, packaged in a) 30-count bottles (NDC 70518-0064-01) and b) 90-count bottles (NDC 70518-0064-00), 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-0496-2023