FDA Drug Class I — Most Serious

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.

Hazard

Presence of Particulate Matter

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Products

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 6745
Brand
Mylan Institutional LLC
UPC
Lot #: 7801221, 7801222, Exp 03/16

Units Affected

2,455 vials

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