Argatroban recalls
The FDA has published 3 recalls involving Argatroban since 2016. The latest was reported on 19 Sep 2018. Most were for potency & assay. Pfizer has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.
Total recalls3since 2016
Last 12 months0reported
Class I00% of total
Ongoing0latest 19 Sep 2018
Recalls per month, last 24 months
click a bar for that monthSeverity split
Class I 0 0%Class II 1 33%Class III 2 67%
Why argatroban is recalled
Companies
By year
All argatroban recalls, newest first
3 total| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Argatroban Injection, 250 mg/ (100 mg/mL) Single-use Vial recalled | Pfizer | Potency & Assay | Nationwide |
| Drug | CLASS III | Argatroban Injection, 250 mg/ (100 mg/mL) Single-use vial recalled | Hospira Inc. A Pfizer | Potency & Assay | Nationwide |
| Drug | CLASS II | Argatroban Injection in 0.9% Sodium Chloride 250 mg/ (1 mg/mL) recalled | Teva North America | Manufacturing (CGMP) Deviations | Nationwide |
Should you stop taking Argatroban?
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.