FDA Recall D-1332-2015

Mylan Institutional LLC · Rockford, IL

Class I — life-threatening Terminated 424 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.

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.

Lot / code: Lot #: a) 7801396, 7801398, 7801401, 7801406, Exp 08/16; 7801427, Exp 09/16; b) 7801089, 7801084, Exp 07/15; 7801110, Exp 08/15

Quantity: a) 35,197 vials; b) 21,302 vials

Reason for recall

Presence of Particulate Matter

Recall record

Recall number: D-1332-2015
Classification: Class I
Status: Terminated
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide and Puerto Rico
Recall initiated: 2015-03-23
Classified by FDA Center: 2015-08-14
FDA published: 2015-08-26
Terminated: 2016-05-20
Recalling firm: Mylan Institutional LLC
Firm location: Rockford, IL

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