D-832-2013 Class I Terminated
FDA drug recall D-832-2013 was initiated by Sandoz Incorporated on May 20, 2013 and is designated Class I. Reason for recall: Presence of Particulate Matter: Found during examination of retention samples. The recall status is terminated (terminated January 29, 2014). Affected quantity: 1,635 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- August 14, 2013
- Initiation Date
- May 20, 2013
- Termination Date
- January 29, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,635 vials
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.
Distribution Pattern
Nationwide
Code Information
Lot #: CL0996, Exp 12/13; and CJ4948, Exp 05/13