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

FDA recall notice · announced July 31, 2013 · Pharmalucence

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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

Reason for recall

Presence of Particulate Matter; particulate found in retain samples

Notes

Distribution: Nationwide & Bahamas, Barbados, Bermuda, Japan
Lot/code information: Lot 280011, Exp 08/13
Quantity: 17,260 vials
Status: Terminated
Products in this recall event:
- 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) Thirt (D-808-2013)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.