Drug product
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
D-808-2013
Product summary
- Event
- Event 65244
- Status
- Terminated
- Classification
- Class III
- Quantity
- 17,260 vials
- Official record key
drug-enforcement:D-808-2013
Official wording
Reason: Presence of Particulate Matter; particulate found in retain samples
Code information: Lot 280011, Exp 08/13
Distribution pattern: Nationwide & Bahamas, Barbados, Bermuda, Japan
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter