Accord Healthcare, Inc. recalls Bivalirudin for Injection 250 mg, 10 Single-Dose Vials, Rx Only, Manufactured for: Accord Healthcare, Inc. Durham, NC 27
Recalled July 19, 2023 · FDA recall D-0918-2023 · Accord Healthcare
Hazard
Presence of Particulate Matter: Particulate matter identified as fiber. · FDA Class II
Units
1680 vials
Sold at
Nationwide within the United States
Description
Presence of Particulate Matter: Particulate matter identified as fiber.
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.
Manufacturer(s)
Accord Healthcare, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →