Recall: D-0918-2023

Class II - Potentially Harmful

Class IIClassification

2023-07-03Initiated

TerminatedStatus

Accord Healthcare, Inc.Firm

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

Presence of Particulate Matter: Particulate matter identified as fiber.

Distribution

Nationwide within the United States

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.