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SafetyAlerts
December 20, 2001

Ben Venue Has Recalled Cardiolite

Bedford, OH (SafetyAlerts) - The Food and Drug Administration (FDA) said that Ben Venue Laboratories, Inc. has recalled Cardiolite.

PRODUCT
Cardiolite (kit for the preparation of technetium Tc99m Sestamibi for injection), 5ml vial packaged in a 5 vial kit. Recall # D-050-2.

CODE
Lot Number 3749; Exp. 1 Apr ?03

RECALLING FIRM/MANUFACTURER
Ben Venue Laboratories, Inc., Bedford, OH., by fax on 11/9/01. Firm-initiated recall ongoing.

REASON
Lack of assurance of sterility (Vial seal integrity) VOLUME OF PRODUCT IN COMMERCE 3,543 kits (5-vial kits)

DISTRIBUTION
Nationwide, Aman, Guam.

 
Selected Recent Recalls


Health Professional:

Did you know?
During 2000 there were over
1050 products recalled in the United
States for safety reasons!

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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.