FDAFDA · Food and drugs·Recall number D-808-2013
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
Published July 31, 2013 · Recall initiated: May 30, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Presence of Particulate Matter; particulate found in retain samples
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Pharmalucence, Inc.
- Distributor
- Nationwide & Bahamas, Barbados, Bermuda, Japan
- Lot
- Lot 280011, Exp 08/13
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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