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U.S. Department of Health and Human Services

Enforcement Report - Week of July 31, 2013

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Event Detail

Event ID 65244
Product Type Drugs
Status Ongoing
Recalling Firm Pharmalucence, Inc.
City Billerica
State MA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-05-30
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Nationwide & Bahamas, Barbados, Bermuda, Japan

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Pharmalucence Kit for the Preparation of Technetium Tc 99m Sestamibi Injection for Mycardial and Breast Imaging. For Intravenous Use and Reconstitution. a) Five vials kits: NDC# 45567-0555-1, b) Thirty vials kits: NDC# 45567-0555-2, Rx Only, Manufactured by: Pharmalucence, Inc., Billerica, MA 01821 Lot 280011, Exp 08/13 Class III Presence of Particulates; particulate found in retain sample 17,260 vials D-808-2013
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