FDA recall D-0918-2023

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.

Reason for recall

Presence of Particulate Matter: Particulate matter identified as fiber.

Distribution

Nationwide within the United States

Key facts

Status

Terminated

Initiation date

2023-07-03

Report date

2023-07-19

Termination date

2024-10-17

Voluntary/Mandated

Voluntary: Firm initiated

Location

Durham, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0918-2023