Mylan Institutional LLC recalls Gemcitabine for Injection, USP, 2 g*/vial, Lyophilized powder in a Single-Use Vial, Rx only, Manufactured for: Mylan In…
- Recall date
- March 23, 2015
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-1333-2015
- 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, 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.
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