FDA recall D-832-2013

Sandoz Incorporated · Class I · drug

Product

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

Nationwide

Key facts

Status: Terminated
Initiation date: 2013-05-20
Report date: 2013-08-14
Termination date: 2014-01-29
Voluntary/Mandated: Voluntary: Firm initiated
Location: Broomfield, CO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-832-2013