Drug Enforcement D-832-2013

Presence of Particulate Matter: Found during examination of retention samples.

Status

Terminated

Classification

Class I

Report Date

August 14, 2013

Termination Date

January 29, 2014

Product Information

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.
Product quantity
1,635 vials
Reason for recall
Presence of Particulate Matter: Found during examination of retention samples.
Recall initiation reason
—
Initial firm notification
Press Release
Distribution pattern
Nationwide

Location & Firm

Recalling firm
Sandoz Incorporated
Address
2555 W Midway Blvd, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-832-2013
Event ID
65200
Recall initiation date
May 20, 2013
Center classification date
August 2, 2013
Code info
Lot #: CL0996, Exp 12/13; and CJ4948, Exp 05/13
More code info
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