FDA-Drug2013-08-14Class I

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.

Sandoz Incorporated
Hazard

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

Sold states
Nationwide
Affected count
1,635 vials
Manufactured in
2555 W Midway Blvd, N/A, Broomfield, CO, United States
Products
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.

Official notice

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

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