May 2013 FDA Recall Drug by Pharmalucence, Inc.
D-808-2013 - Presence of Particulate Matter; particulate found in retain samples

This Class III drug recall was voluntarily initiated by Pharmalucence, Inc. on May 30, 2013 for the product Drug. The FDA reported the reason for recall as presence of particulate matter; particulate found in retain samples. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-808-2013

Reason for Recall
Presence of Particulate Matter; particulate found in retain samples
Initiated
05-30-2013
Reported
07-31-2013
Quantity
17,260 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
65244
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharmalucence, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide & Bahamas, Barbados, Bermuda, Japan
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-17-2013
Product Description About Product Description
Full technical description of 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

Batch or Lot Expiration Information

Lot# Lot 280011, Exp 08/13