Status
Terminated
Drug Enforcement D-0918-2023
Presence of Particulate Matter: Particulate matter identified as fiber.
Classification
Class II
Report Date
July 19, 2023
Termination Date
October 17, 2024
Product Information
- 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.
- Product quantity
- 1680 vials
- Reason for recall
- Presence of Particulate Matter: Particulate matter identified as fiber.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide within the United States
Location & Firm
- Recalling firm
- ACCORD HEALTHCARE, INC.
- Address
-
1009 Slater Rd Ste 210B, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0918-2023
- Event ID
- 92639
- Recall initiation date
- July 3, 2023
- Center classification date
- July 13, 2023
- Code info
- Lot #: M2212070 Exp. date 08/2024
- More code info
- —