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U.S. Department of Health and Human Services

Enforcement Report - Week of June 19, 2013

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Event Detail

Event ID 65318
Product Type Drugs
Status Ongoing
Recalling Firm Sandoz Incorporated
City Broomfield
State CO
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-05-30
Initial Firm Notification of
Consignee or Public
Distribution Pattern Nationwide and Puerto Rico.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Cefazolin, injection, 1 gram per vial, 25 vials per box, sterile, Rx only, single-use vial, Manufactured in Austria by Sandoz GmbH for Sandoz, Inc. Princeton, NJ 08540, NDC 00781-3451-70 (vial), NDC 00781-3451-96 (box) Lot #: DB2208, Exp 01/16 Class II Lack of Assurance of Sterility: Sandoz Inc is recalling Cefazolin for Injection, USP 1 gm vials, lot DB2208, due to a customer complaint for broken/cracked vials which was confirmed through review of retained samples. 297,200 vials D-597-2013