Drug 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.
D-832-2013
Product summary
- Event
- Event 65200
- Status
- Terminated
- Classification
- Class I
- Quantity
- 1,635 vials
- Official record key
drug-enforcement:D-832-2013
Official wording
Reason: Presence of Particulate Matter: Found during examination of retention samples.
Code information: Lot #: CL0996, Exp 12/13; and CJ4948, Exp 05/13
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter