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SafetyAlerts
November 26,  2003

Mallinckrodt Has Recalled TechneScan MAA

(SafetyAlerts) - The FDA has released the following information.

PRODUCT
TechneScan MAA, Technetium TC 99m Albumin Aggregated Injection and Kit (Lyophilized), Kit for the preparation of Technetium Tc 99m Albumin Aggregated, Rx Only, packaged in 5-vial kits or 30-vial kits. Recall # D-058-4.

CODE
Lot Number/Exp. Date:
0932024, Exp. 9/18/03;
0932026, Exp. 9/25/03;
0932027, Exp. 9/30/03;
0932028, Exp. 10/7/03;
0932030, Exp. 10/16/03;
0932031, Exp. 10/21/03;
0932032, Exp. 10/28/03;
0932033, Exp. 10/30/03;
0932034, Exp. 11/13/03;
0932035, Exp. 11/20/03;
0932036, Exp. 11/25/03,
0932037, Exp. 12/3/03;
0932038, Exp. 12/9/03;
0932039, Exp. 12/18/03;
0933001, Exp. 1/6/04;
0933005, Exp. 3/10/04;
0933006, Exp. 3/12/04;
0933007, Exp. 3/17/04;
0933008, Exp. 3/24/04;
0933009, Exp. 3/26/04;
0933010, Exp. 3/31/04;
0933013, Exp. 5/19/04;
0933014, Exp. 5/21/04;
0933015, Exp. 6/2/04;
0933016, Exp. 6/4/04;
0933018, Exp. 6/25/04;
0933019, Exp. 7/7/04.

RECALLING FIRM/MANUFACTURER
Mallinckrodt, Inc., Maryland Heights, MO, by letter dated September 23, 2003. FDA initiated recall is ongoing.

REASON
Good Manufacturing Practice Deviations (GMPs) leading to product process variability within the manufacturing/sterility/validation process(es) which result in poor diagnostic scans (including but not limited to altered biodistribution/radiochemical impurity).

VOLUME OF PRODUCT IN COMMERCE
98,495 vials.

DISTRIBUTION
Nationwide and Internationally.

 
Selected Recent Recalls


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During 2000 there were over
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The information contained herein has been obtained from sources that the Company believes to be reliable, however, the Company has not independently verified or confirmed the information and the recipient acknowledges that no representations or warranties are being made in connection with the use of the information.