January 5, 2000Steris 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
FDA Recall #D-160-0.
Questions concerning this recall may
be directed to the FDA at 1-888-INFO-FDA.
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