FDA-Drug2015-08-26Class I

Gemcitabine for Injection, USP, 1 g*/vial, Lyophilized powder in a Single-Use Vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103, Made in India, NDC 67457-462-01, UPC 3 67457 46201 1.

Mylan Institutional LLC
Hazard

Presence of Particulate Matter

Sold states
Nationwide and Puerto Rico
Affected count
10,094 vials
Manufactured in
4901 Hiawatha Dr, Rockford, IL, United States
Products
Gemcitabine for Injection, USP, 1 g*/vial, Lyophilized powder in a Single-Use Vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103, Made in India, NDC 67457-462-01, UPC 3 67457 46201 1.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1334-2015

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