Reported Jul 31, 2013 · Terminated
Pharmalucence Kit for the Preparation of Technetium Tc 99m Sestamibi Injection for Mycardial and Breast Imaging. For…
Pharmalucence, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Pharmalucence, Inc. · 29 Dunham Rd · Billerica, MA · 01821
Is this the product you have?
- Pharmalucence Kit for the Preparation of Technetium Tc 99m Sestamibi Injection for Mycardial and Breast Imaging. For Intravenous Use and Reconstitution
- a) Five vials kitsNDC# 45567-0555-1
- b) Thirty vials kitsNDC# 45567-0555-2, Rx Only
- Manufactured byPharmalucence, Inc., Billerica, MA 01821
- Lot codes and dates
Lot 280011Exp 08/13
- Amount recalled
- 17,260 vials
Where it was sold
- Nationwide
Why it was recalled
Presence of Particulate Matter; particulate found in retain samples
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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