April 12, 2000CIS-Sulfur Colloid Kit
Bedford, MA (SafetyAlerts) - The Food and Drug
Administration (FDA) today reported that CIS-US Inc. is recalling CIS-Sulfur Colloid
Kits because solution B vial has reversed the strength (mg/ml) of the two
ingredients on its immediate vial label.
The recalled CIS-Sulfur Colloid
Kit (Technetium Tc 99m Sulfur Colloid Injection) is used in adults and children as an
agent for imaging areas of functioning reticuloendothelial cells in the liver, spleen and
bone marrow. The recalled products bear one of the following lot numbers and
According to the FDA, approximately
11,500 units were distributed nationwide. All lots within expiration date are affected by
this recall. The product was distributed nationwide, New Zealand, Panama, Puerto
Rico and Guam.
This ongoing Class III recall
was initiated by CIS-US Inc., by letter on February 23, 2000. This is the first
public notice issued by the FDA.
Questions concerning this recall may
be directed to the FDA at 1-888-INFO-FDA.
FDA Recall #d-262-0
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