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D-808-2013 Class III Terminated

Recalled by Pharmalucence, Inc. — Billerica, MA

FDA drug recall D-808-2013 was initiated by Pharmalucence, Inc. on May 30, 2013 and is designated Class III. Reason for recall: Presence of Particulate Matter; particulate found in retain samples The recall status is terminated (terminated October 17, 2013). Affected quantity: 17,260 vials.

Recall Details

Product Type: Drugs
Report Date: July 31, 2013
Initiation Date: May 30, 2013
Termination Date: October 17, 2013
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 17,260 vials

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

Reason for Recall

Presence of Particulate Matter; particulate found in retain samples

Distribution Pattern

Nationwide & Bahamas, Barbados, Bermuda, Japan

Code Information

Lot 280011, Exp 08/13