Mylan Institutional LLC recalls Gemcitabine for Injection, USP, 200 mg*/vial, Lyophilized powder in a Single-Use Vial, Rx only, labeled as a) Manufactu…

Recall date

March 23, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-1332-2015

FDA classification

Class I

Brand / firm

Mylan Institutional LLC

Sold / distributed

Nationwide and Puerto Rico

Why it was recalled

Presence of Particulate Matter

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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.