Drug FDA Class II Ongoing cGMP deviation
Clindamycin HCl Capsule, 300 mg, QTY: 30 Capsules per bottle, Rx Only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701. NDC#: 70518-3772-02
RemedyRePack Inc. Published May 14, 2025
Risk level
Class IIMay cause a temporary or reversible health problem; slight chance of serious harm.
Severity score 50/100
What should you do?
- Check whether you have this product, using the lot codes, UPCs, and dates listed below.
- Do not eat, serve, or sell the affected product.
- Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
- Contact RemedyRePack Inc. or your place of purchase with questions, and see the source record below for full details.
Reason for recall
CGMP Deviations - products manufactured in a shared facility with Ezetimibe tablets.
Hazards
Shared Facility Manufacturing with Ezetimibe · primary
Affected products (1)
Clindamycin HCl Capsule, 300 mg, QTY: 30 Capsules per bottle, Rx Only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701. NDC#: 70518-3772-02
23 bottles/30 count- 690 capsules
Code info: Lot#: B3698036-033125, B3688703-032625, Exp.: 07/31/2026.
Affected areas
FloridaPennsylvaniaVirginia
Timeline
- InitiatedApr 22, 2025
- PublishedMay 14, 2025
- Recall number
- D-0411-2025
- Agency
- U.S. Food and Drug Administration
- Country
- US
FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.