Recalls / Class I
Class ID-832-2013
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences 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.
- Affected lot / code info
- Lot #: CL0996, Exp 12/13; and CJ4948, Exp 05/13
Why it was recalled
Presence of Particulate Matter: Found during examination of retention samples.
Recalling firm
- Firm
- Sandoz Incorporated
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 2555 W Midway Blvd, N/A, Broomfield, Colorado 80020-1632
Distribution
- Quantity
- 1,635 vials
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2013-05-20
- FDA classified
- 2013-08-02
- Posted by FDA
- 2013-08-14
- Terminated
- 2014-01-29
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-832-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.