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SafetyAlerts
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.

Code(s):
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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