Drug 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.
D-1328-2015
Product summary
- Event
- Event 70936
- Status
- Terminated
- Classification
- Class I
- Quantity
- a) 15,095 vials b) 300 vials
- Official record key
drug-enforcement:D-1328-2015
Official wording
Reason: Presence of Particulate Matter
Code information: Lot #: a) 7801082, Exp. 07/15 and b) 7801421, Exp. 09/16
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter