Recalls / Class III
Class IIID-808-2013
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
- Affected lot / code info
- Lot 280011, Exp 08/13
Why it was recalled
Presence of Particulate Matter; particulate found in retain samples
Recalling firm
- Firm
- Pharmalucence, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 29 Dunham Rd, N/A, Billerica, Massachusetts 01821
Distribution
- Quantity
- 17,260 vials
- Distribution pattern
- Nationwide & Bahamas, Barbados, Bermuda, Japan
Timeline
- Recall initiated
- 2013-05-30
- FDA classified
- 2013-07-19
- Posted by FDA
- 2013-07-31
- Terminated
- 2013-10-17
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-808-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.