Accord Healthcare, Inc.: Drug Recall

Recall #D-0918-2023 · 07/03/2023

Class II: Risk

Recall Details

Recall Number
D-0918-2023
Classification
Class II
Product Type
Drug
Recalling Firm
Accord Healthcare, Inc.
Status
Terminated
Date Initiated
07/03/2023
Location
Durham, NC, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1680 vials

Reason for Recall

Presence of Particulate Matter: Particulate matter identified as fiber.

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.

Distribution Pattern

Nationwide within the United States

Other Recalls by Accord Healthcare, Inc.

View all recalls by Accord Healthcare, Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.