Mylan Institutional LLC recalls Gemcitabine for Injection, USP, 2 g*/vial, Lyophilized powder in a Single-Use Vial, Rx only, Manufactured for: Mylan Ins
Recalled August 26, 2015 · FDA recall D-1333-2015 · Mylan Institutional
Hazard
Presence of Particulate Matter · FDA Class I
Units
2,455 vials
Sold at
Nationwide and Puerto Rico
Description
Presence of Particulate Matter
Product
Gemcitabine for Injection, USP, 2 g*/vial, Lyophilized powder in a Single-Use Vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103, Made in India, NDC 67457-463-02, UPC 3 67457 46302 5.
Manufacturer(s)
Mylan Institutional LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →