Recall archive / FDA drug enforcement
Clindamycin HCl Capsule, 300 mg, QTY: 30 Capsules per bottle, Rx Only, Repackaged by: RemedyRepack Inc., Indiana, PA ... — FDA record D-0411-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Apr 22, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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
- CGMP Deviations - products manufactured in a shared facility with Ezetimibe tablets.
- Classification
- Class II
- Recalling firm
- RemedyRePack Inc.
- Quantity
- 23 bottles/30 count- 690 capsules
- Agency-reported status
- Ongoing
- Source record identifier
- D-0411-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Lot#: B3698036-033125, B3688703-032625, Exp.: 07/31/2026. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Within U.S - PA, VA, FL.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- May 14, 2025
- Recall initiation date
- Apr 22, 2025
- Center classification date
- May 6, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.