D-1328-2015 Class I Terminated

Recalled by Mylan Institutional LLC — Rockford, IL

Recall Details

Product Type
Drugs
Report Date
August 19, 2015
Initiation Date
March 18, 2015
Termination Date
June 29, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
a) 15,095 vials b) 300 vials

Product Description

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

Distribution Pattern

Nationwide and Puerto Rico

Code Information

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