FDA recall D-0411-2025

RemedyRePack Inc. · Class II · drug

Product

Clindamycin HCl Capsule, 300 mg, QTY: 30 Capsules per bottle, Rx Only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701. NDC#: 70518-3772-02

Reason for recall

CGMP Deviations - products manufactured in a shared facility with Ezetimibe tablets.

Distribution

Within U.S - PA, VA, FL.

Key facts

Status
Ongoing
Initiation date
2025-04-22
Report date
2025-05-14
Voluntary/Mandated
Voluntary: Firm initiated
Location
Indiana, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0411-2025