Argatroban Injection 50 mg per 50ml — Class I drug recall D-1429-2012
Terminated recall by Eagle Pharmaceuticals Inc., reported 2012-08-08, distributed in NJ. A complaint was received from a hospital pharmacy on 11/10/11 for crystalline particulates in a single vial fr
| Recall number | D-1429-2012 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Eagle Pharmaceuticals Inc., Woodcliff Lake, NJ, United States |
| Recall initiated | 2011-12-02 |
| Classified | 2012-07-31 |
| Reported by FDA | 2012-08-08 |
| Terminated | 2013-06-03 |
| Distributed | NJ |
| Quantity | 19,660 vials |
| Reason classes | specification failure |
| NDC | 42367-0203-07, 42367-0203-84 |
| Lot numbers | 01/13, 02/13, V10189, V10191, V10194, V10223 |
Product
Argatroban Injection 50 mg per 50ml (1 mg per ml) For Intravenous Infusion Only, a) Single Use Vial (NDC 42367-203-07), b) 10 Single Use Vials(NDC 42367-203-84), Rx Only, Manufactured by: Cipla LTD, India, Manufactured for: Eagle Pharmaceuticals, Inc. Woodcliff Lake, NJ 07677 USA, Marketed by: The Medicines Company, Parsippany, NJ 07054 USA
Reason for recall
A complaint was received from a hospital pharmacy on 11/10/11 for crystalline particulates in a single vial from Lot V10194. Additional small visible particles consisting of fibers were identified.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1429-2012. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.