Reported Aug 8, 2012 · Terminated
Argatroban Injection 50 mg per 50ml (1 mg per ml) For Intravenous Infusion Only, a) Single Use Vial (NDC 42367-203-07),…
Eagle Pharmaceuticals Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Eagle Pharmaceuticals Inc. · 470 Chestnut Ridge Rd · Woodcliff Lake, NJ · 07677-7604
Is this the product you have?
- 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 byCipla LTD, India
- Manufactured forEagle Pharmaceuticals, Inc. Woodcliff Lake, NJ 07677 USA
- Marketed byThe Medicines Company, Parsippany, NJ 07054 USA
- Lot codes and dates
Lot #V10189Lot #V10191Lot #V10194Exp 01/13Lot #V10223Exp 02/13
- Amount recalled
- 19,660 vials
Where it was sold
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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