D-0918-2023 Class II Terminated
FDA drug recall D-0918-2023 was initiated by Accord Healthcare, Inc. on July 3, 2023 and is designated Class II. Reason for recall: Presence of Particulate Matter: Particulate matter identified as fiber. The recall status is terminated (terminated October 17, 2024). Affected quantity: 1680 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- July 19, 2023
- Initiation Date
- July 3, 2023
- Termination Date
- October 17, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1680 vials
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.
Reason for Recall
Presence of Particulate Matter: Particulate matter identified as fiber.
Distribution Pattern
Nationwide within the United States
Code Information
Lot #: M2212070 Exp. date 08/2024