Class I — High risk. Reasonable probability of serious harm or death.
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.
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
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Failed Impurities/Degradation Specifications; Out of specification stability testing results at the 18 month time point
Reason Failed Impurities/Degradation Specifications; out of specification result for denitroquinoline-related impurity during three month time point
Reason CGMP Deviations
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