FDA Recall D-832-2013
Sandoz Incorporated · Broomfield, CO
Class I — life-threatening Terminated 254 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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.
Recall record
- Recall number
D-832-2013- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- Nationwide
- Recall initiated
- 2013-05-20
- Classified by FDA Center
- 2013-08-02
- FDA published
- 2013-08-14
- Terminated
- 2014-01-29
- Recalling firm
- Sandoz Incorporated
- Firm location
- Broomfield, CO