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U.S. Department of Health and Human Services

Enforcement Report - Week of July 31, 2013

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Product Detail

Product Description 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
Recall Number D-808-2013
Classification Class III
Code Info Lot 280011, Exp 08/13
Product Distributed Qty 17,260 vials
Reason For Recall Presence of Particulates; particulate found in retain sample

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