Why it was recalled
Presence of Particulate Matter: Particulate matter identified as fiber.
Product description
Bivalirudin for Injection 250 mg, 10 Single-Dose Vials, Rx Only, Manufactured for: Accord Healthcare, Inc. Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited Ahmedabad-382 210, India, NDC 16729-275-67.
Lot numbers, UPCs & expiration codes
Lot #: M2212070 Exp. date 08/2024
Where it was sold
Nationwide within the United States
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-0918-2023
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 3, 2023
- FDA report date
- Jul 19, 2023
- Quantity
- 1680 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Accord Healthcare, Inc.
Original FDA data
Every field from FDA enforcement report D-0918-2023, exactly as published.
Show all FDA fields
- City
- Durham
- State
- NC
- Status
- Terminated
- Country
- United States
- Event ID
- 92639
- Address
- 1009 Slater Rd Ste 210B
- Code information
- Lot #: M2212070 Exp. date 08/2024
- Postal code
- 27703-8446
- Report date
- Jul 19, 2023
- Product type
- Drugs
- Recall number
- D-0918-2023
- Classification
- Class II
- Recalling firm
- Accord Healthcare, Inc.
- Product quantity
- 1680 vials
- Termination date
- Oct 17, 2024
- Reason for recall
- Presence of Particulate Matter: Particulate matter identified as fiber.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Bivalirudin for Injection 250 mg, 10 Single-Dose Vials, Rx Only, Manufactured for: Accord Healthcare, Inc. Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited Ahmedabad-382 210, India, NDC 16729-275-67.
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Jul 3, 2023
- Initial firm notification
- Letter
- Center classification date
- Jul 13, 2023