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January 5, 2000

Steris Recalls Certain Lots of SeptisolÆ Solution

Mentor, OH (SafetyAlerts) - The Food and Drug Administration (FDA) today reported that Steris Corporation has recalled certain lots of its SeptisolÆ Solution because of subpotency (9-month stability).

This onging Class III recall was initiated by Steris - by letter dated November 18, 1999.  This is the first public notice issued by the FDA.

Product described as:
SeptisolÆ Solution, Handwash, Triclosan 0.25%, in 8-ounce, 1- quart, and 1-gallon plastic containers, OTC broad spectrum, fast acting handwash to decrease the level of transient microorganisms on the skin before contact with patients under medical care or treatment.

217034 EXP 12/31/1999
217309, EXP 1/31/2000
218107, EXP 3/31/2000
218134, EXP 3/31/2000
218748, EXP 6/30/2000
219650, EXP 9/31/2000 and EXP 10/31/2000 220065, EXP 11/30/2000.

481 (48 8-fluid ounce bottle) cases, 2,426 (12 1-quart bottle) cases, and 12,106 (4 1-galllon bottle) cases were distributed nationwide.

FDA Recall #D-160-0.

Questions concerning this recall may be directed to the FDA at 1-888-INFO-FDA.

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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