FDAClass IAugust 26, 2015

Gemcitabine for Injection recall: Particulate Matter

Gemcitabine for Injection, USP, 2 g*/vial, Lyophilized powder in a Single-Use Vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL…

Why was Gemcitabine for Injection recalled?

Presence of Particulate Matter

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: 7801221, 7801222, Exp 03/16

Product
Gemcitabine for Injection, USP, 2 g*/vial, Lyophilized powder in a Single-Use Vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL…
Recalling firm
Mylan Institutional LLC
Quantity
2,455 vials
Distribution
Nationwide and Puerto Rico
Recall date
August 26, 2015
Classification
Class I
Status
Terminated
Agency
FDA (drug)
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