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April 12, 2000

CIS-Sulfur Colloid™ Kit   Recalled

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 expirations dates:
6363A 12/31/99
6364 1/31/00
6365A 1/31/00
6366A 2/29/00
6367A 1/31/00
6368 2/29/00
6369 2/29/00
6370A 3/31/00
6371 4/30/00
6372 4/30/00
6373B 4/30/00
6374B 6/30/00
6375B 9/30/00
6376 10/31/00
6377B 12/31/00.

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

Selected Recent Recalls

Health Professional:

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

How many did you hear about?

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