Why it was recalled
CGMP Deviations - products manufactured in a shared facility with Ezetimibe tablets.
Product description
Clindamycin HCl Capsule, 300 mg, QTY: 30 Capsules per bottle, Rx Only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701. NDC#: 70518-3772-02
Lot numbers, UPCs & expiration codes
Lot#: B3698036-033125, B3688703-032625, Exp.: 07/31/2026.
Where it was sold
Within U.S - PA, VA, FL.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0411-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Apr 22, 2025
- FDA report date
- May 14, 2025
- Quantity
- 23 bottles/30 count- 690 capsules
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- RemedyRePack Inc.
Original FDA data
Every field from FDA enforcement report D-0411-2025, exactly as published.
Show all FDA fields
- City
- Indiana
- State
- PA
- Status
- Ongoing
- Country
- United States
- Event ID
- 96764
- Address
- 625 Kolter Dr Ste 4
- Code information
- Lot#: B3698036-033125, B3688703-032625, Exp.: 07/31/2026.
- Postal code
- 15701-3571
- Report date
- May 14, 2025
- Product type
- Drugs
- Recall number
- D-0411-2025
- Classification
- Class II
- Recalling firm
- RemedyRePack Inc.
- Product quantity
- 23 bottles/30 count- 690 capsules
- Reason for recall
- CGMP Deviations - products manufactured in a shared facility with Ezetimibe tablets.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Clindamycin HCl Capsule, 300 mg, QTY: 30 Capsules per bottle, Rx Only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701. NDC#: 70518-3772-02
- Distribution pattern
- Within U.S - PA, VA, FL.
- Recall initiation date
- Apr 22, 2025
- Initial firm notification
- Center classification date
- May 6, 2025