Recalls / Class II
Class IID-0378-2025
Product
Clindamycin HCl, 300 mg Capsule, QTY: 30 Capsules per bottle, Rx Only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701. NDC; 70518-3772-00
- Affected lot / code info
- Lot J0826722-121624 Exp. 12/31/2025 Lot J0820365-111324 Exp. 11/30/2025 Lot J0814691-101624 Exp. 10/31/2025
Why it was recalled
CGMP Deviations
Recalling firm
- Firm
- RemedyRepack Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 625 Kolter Dr Ste 4, N/A, Indiana, Pennsylvania 15701-3571
Distribution
- Quantity
- 1,858 30-count blister cards
- Distribution pattern
- PA
Timeline
- Recall initiated
- 2025-03-24
- FDA classified
- 2025-04-18
- Posted by FDA
- 2025-04-30
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0378-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.