Bivalirudin Injection, Powder, Lyophilized, For Solution
FDA Recall NDC 16729-275
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Bivalirudin (NDC 16729-275). A significant event, classified as Class II, was initiated on Jul 03, 2023 by Accord Healthcare, Inc.. The reported reason for this action was: "Presence of Particulate Matter: Particulate matter identified as fiber."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Presence of Particulate Matter: Particulate matter identified as fiber.
Jul 03, 2023
Jul 19, 2023
1680 vials
Recall Profile & Regulatory Data
Event ID
92639
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Accord Healthcare, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Termination Date
Oct 17, 2024
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.
Batch or Lot Expiration Information
Lot# : M2212070 Exp. date 08/2024
Affected Packages Involved in this Recall
16729-275-03Product
16729-275-67Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
