Drug recall D-1328-2015

Class I Terminated reported Aug 19, 2015

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.

Reason for recall

Presence of Particulate Matter

Lots and codes

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

Recall details

Recalling firm
Mylan Institutional LLC, Rockford, IL
Quantity
a) 15,095 vials b) 300 vials
Distribution
Nationwide and Puerto Rico
Type
Voluntary: Firm initiated
Recall initiated
March 18, 2015
Terminated
June 29, 2016