Bivalirudin recalls

The FDA has published 1 recall involving Bivalirudin since 2023. The latest was reported on 19 Jul 2023. Most were for particulate matter. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls1since 2023
Last 12 months0reported
Class I00% of total
Ongoing0latest 19 Jul 2023

Recalls per month, last 24 months

click a bar for that month

Severity split

Class I 0 0%Class II 1 100%Class III 0 0%

Why bivalirudin is recalled

Companies

By year

All bivalirudin recalls, newest first

1 total
ReportedClassRecallCompanyReasonWhere
DrugCLASS IIBivalirudin for Injection 250 mg-Dose Vials recalledBivalirudinAccord HealthcareParticulate MatterNationwide

Should you stop taking Bivalirudin?

Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.