Gemcitabine for Injection recall: Particulate Matter
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.
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 #: a) 7801396, 7801398, 7801401, 7801406, Exp 08/16; 7801427, Exp 09/16; b) 7801089, 7801084, Exp 07/15; 7801110, Exp 08/15
- Product
- 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.
- Recalling firm
- Mylan Institutional LLC
- Quantity
- a) 35,197 vials; b) 21,302 vials
- Distribution
- Nationwide and Puerto Rico
- Recall date
- August 26, 2015
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (drug)