December 20, 2001Ben Venue Has Recalled Cardiolite
Bedford, OH (SafetyAlerts)
- The Food and Drug Administration (FDA) said that Ben Venue Laboratories,
Cardiolite (kit for the preparation of technetium Tc99m Sestamibi for
injection), 5ml vial packaged in a 5 vial kit. Recall # D-050-2.
Lot Number 3749; Exp. 1 Apr ?03
Ben Venue Laboratories, Inc., Bedford, OH., by fax on 11/9/01.
Firm-initiated recall ongoing.
Lack of assurance of sterility (Vial seal integrity) VOLUME OF PRODUCT IN
COMMERCE 3,543 kits (5-vial kits)
Nationwide, Aman, Guam.