Mylan Institutional LLC recalls Gemcitabine for Injection, USP, 200 mg*/vial, Lyophilized powder in a Single-Use Vial, Rx only, labeled as a) Manufactur
Recalled August 26, 2015 · FDA recall D-1332-2015 · Mylan Institutional
Hazard
Presence of Particulate Matter · FDA Class I
Units
a) 35,197 vials; b) 21,302 vials
Sold at
Nationwide and Puerto Rico
Description
Presence of Particulate Matter
Product
Gemcitabine for Injection, USP, 200 mg*/vial, Lyophilized powder in a Single-Use Vial, Rx only, labeled as a) Manufactured for: Mylan Institutional LLC, Rockford, IL 61103, Made in India, NDC 67457-464-20, UPC 3 67457 46420 6; and b) Distributed by Pfizer Labs, Division of Pfizer Inc, New York, NY 10017, Made in India, NDC 0069-3857-10, UPC 3 00693 85710 4.
Manufacturer(s)
Mylan Institutional LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →