Why it was recalled
CGMP Deviations
Product description
Clindamycin HCl, 300 mg Capsule, QTY: 30 Capsules per bottle, Rx Only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701. NDC; 70518-3772-00
Lot numbers, UPCs & expiration codes
Lot J0826722-121624 Exp. 12/31/2025 Lot J0820365-111324 Exp. 11/30/2025 Lot J0814691-101624 Exp. 10/31/2025
Where it was sold
PA
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-0378-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Mar 24, 2025
- FDA report date
- Apr 30, 2025
- Quantity
- 1,858 30-count blister cards
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- RemedyRepack Inc.
Original FDA data
Every field from FDA enforcement report D-0378-2025, exactly as published.
Show all FDA fields
- City
- Indiana
- State
- PA
- Status
- Ongoing
- Country
- United States
- Event ID
- 96627
- Address
- 625 Kolter Dr Ste 4
- Code information
- Lot J0826722-121624 Exp. 12/31/2025 Lot J0820365-111324 Exp. 11/30/2025 Lot J0814691-101624 Exp. 10/31/2025
- Postal code
- 15701-3571
- Report date
- Apr 30, 2025
- Product type
- Drugs
- Recall number
- D-0378-2025
- Classification
- Class II
- Recalling firm
- RemedyRepack Inc.
- Product quantity
- 1,858 30-count blister cards
- Reason for recall
- CGMP Deviations
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Clindamycin HCl, 300 mg Capsule, QTY: 30 Capsules per bottle, Rx Only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701. NDC; 70518-3772-00
- Distribution pattern
- PA
- Recall initiation date
- Mar 24, 2025
- Initial firm notification
- Letter
- Center classification date
- Apr 18, 2025