FDA-Drug2015-08-26Class I
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.
Mylan Institutional LLC
Hazard
Presence of Particulate Matter
Sold states
Nationwide and Puerto Rico
Affected count
a) 35,197 vials; b) 21,302 vials
Manufactured in
4901 Hiawatha Dr, Rockford, IL, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1332-2015Don't want to check this manually?
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