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U.S. Department of Health and Human Services

Enforcement Report - Week of August 14, 2013

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Product Detail

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.
Recall Number D-832-2013
Classification Class I
Code Info Lot #: CL0996, Exp 12/13; and CJ4948, Exp 05/13
Product Distributed Qty 1,635 vials
Reason For Recall Presence of Particulate Matter: Found during examination of retention samples.

Event Detail

Event Id 65200
Product Type Drugs
Status Ongoing
Recalling Firm Sandoz Incorporated
City Broomfield
State CO
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-05-20
Initial Firm Notification of Consignee or Public Press Release
Distribution Pattern Nationwide
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