Status
Terminated
Drug Enforcement D-808-2013
Presence of Particulate Matter; particulate found in retain samples
Classification
Class III
Report Date
July 31, 2013
Termination Date
October 17, 2013
Product Information
- 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
- Product quantity
- 17,260 vials
- Reason for recall
- Presence of Particulate Matter; particulate found in retain samples
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide & Bahamas, Barbados, Bermuda, Japan
Location & Firm
- Recalling firm
- Pharmalucence, Inc.
- Address
-
29 Dunham Rd, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-808-2013
- Event ID
- 65244
- Recall initiation date
- May 30, 2013
- Center classification date
- July 19, 2013
- Code info
- Lot 280011, Exp 08/13
- More code info
- —