Recalls / Class II
Class IID-0411-2025
Product
Clindamycin HCl Capsule, 300 mg, QTY: 30 Capsules per bottle, Rx Only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701. NDC#: 70518-3772-02
- Affected lot / code info
- Lot#: B3698036-033125, B3688703-032625, Exp.: 07/31/2026.
Why it was recalled
CGMP Deviations - products manufactured in a shared facility with Ezetimibe tablets.
Recalling firm
- Firm
- RemedyRePack Inc.
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 625 Kolter Dr Ste 4, N/A, Indiana, Pennsylvania 15701-3571
Distribution
- Quantity
- 23 bottles/30 count- 690 capsules
- Distribution pattern
- Within U.S - PA, VA, FL.
Timeline
- Recall initiated
- 2025-04-22
- FDA classified
- 2025-05-06
- Posted by FDA
- 2025-05-14
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0411-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.