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.
Reported: August 14, 2013 Initiated: May 20, 2013 #D-832-2013
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.
Details
- Recalling Firm
- Sandoz Incorporated
- Units Affected
- 1,635 vials
- Distribution
- Nationwide
- Location
- Broomfield, CO
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Sandoz Incorporated. Units affected: 1,635 vials.
Why was this product recalled? ▼
Presence of Particulate Matter: Found during examination of retention samples.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 14, 2013. Severity: Critical. Recall number: D-832-2013.
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