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.

FDA recall notice · announced August 14, 2013 · Sandoz

Class I FDA/FSIS Class I: reasonable probability that use will cause serious adverse health consequences or death.

The 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.

Notes

Distribution: Nationwide
Lot/code information: Lot #: CL0996, Exp 12/13; and CJ4948, Exp 05/13
Quantity: 1,635 vials
Status: Terminated
Products in this recall event:
- 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. (D-832-2013)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.