Drug product
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.
D-0918-2023
Product summary
- Event
- Event 92639
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1680 vials
- Official record key
drug-enforcement:D-0918-2023
Official wording
Reason: Presence of Particulate Matter: Particulate matter identified as fiber.
Code information: Lot #: M2212070 Exp. date 08/2024
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter