D-832-2013 Class I Terminated

Recalled by Sandoz Incorporated — Broomfield, CO

Recall Details

Product Type
Drugs
Report Date
August 14, 2013
Initiation Date
May 20, 2013
Termination Date
January 29, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1,635 vials

Product Description

Methotrexate Injection, USP, Preservative-Free, 1 g/40 mL (25 mg/mL), 40 mL Single Dose Vial, Rx only, Manufactured for: Sandoz Inc., Princeton, NJ 08540; Manufactured by: EBEWE Pharma Ges.m.b.H. Nfg.KG, A-4866 Unterach, AUSTRIA, NDC 66758-041-01.

Reason for Recall

Presence of Particulate Matter: Found during examination of retention samples.

Distribution Pattern

Nationwide

Code Information

Lot #: CL0996, Exp 12/13; and CJ4948, Exp 05/13