August 24, 2010
With knowledge of the U.S. Food and Drug Administration (FDA), Pharmalucence, Inc. has issued voluntary drug recalls of its DTPA lots 2414 and 2416 and Pulmolite® Lot 160034.
Recent testing data of Phamalucence DTPA (Kit for the Preparation of Technetium Tc99m Pentetate Injection) indicate that these two lots do not maintain 90% Radiochemical Purity for up to six hours after reconstruction with up to 160 mCi of Technetium Tc99m. The DTPA package insert instructions state that the reconstituted product may be used up to 6 hours after reconstitution.
Additionally, lot stability testing of Pulmolite® (Kit for the Preparation of Technicium Tc99m Albumin Aggregated for Injection), Lot 160034, indicates that lower than expected particle numbers may be present. Recent testing does not confirm that the average particle count reflects the expected value of 4.3 million particles per vial in this lot.
To view the Customer Letters wth recall instructions for these products, click on the links below: