FDA Recall D-1328-2015

Mylan Institutional LLC · Rockford, IL

Class I — life-threatening Terminated 469 days on record

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

Product

Methotrexate Injection, USP 50 mg/2 mL (25 mg/mL), 2 mL Single-dose Vial, packaged in 5 x 2 mL vials per carton, Rx only, labeled as a) Distributed by Pfizer Labs, Division of Pfizer Inc., New York, NY 10017, NDC 0069-0146-01; and b) Manufactured for: Mylan Institutional LLC, Rockford, IL 61103, NDC 67457-467-99.

Lot / code: Lot #: a) 7801082, Exp. 07/15 and b) 7801421, Exp. 09/16

Quantity: a) 15,095 vials b) 300 vials

Reason for recall

Presence of Particulate Matter

Recall record

Recall number: D-1328-2015
Classification: Class I
Status: Terminated
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide and Puerto Rico
Recall initiated: 2015-03-18
Classified by FDA Center: 2015-08-13
FDA published: 2015-08-19
Terminated: 2016-06-29
Recalling firm: Mylan Institutional LLC
Firm location: Rockford, IL

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