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April 12, 2000

CombiPatch™ Transdermal System  Recalled

Collegeville, PA (SafetyAlerts) - The Food and Drug Administration (FDA) today reported that Aventis, is recalling CombiPatch™ Transdermal System because of dissolution and appearance specification failure (excess crystals).

The recalled CombiPatch™ Transdermal System, (estradiol-0.62 mg/norethindrone acetate-2.7mg),  NDC #0075-0514-08, is a prescription used by women, with an intact uterus, for treatment of moderate to severe vasomotor symptoms associated with menopause. treatment of vulvar and vaginal atrophy, and treatment of hypoestrogenism due to hypogonadism, castration, or primary ovarian failure. 

The recalled products bears of the Lot Numbers of 8F0308E1C1 EXP 4/00 or 9D2703E1C1 EXP 2/01.

According to the FDA, approximately 65,000 boxs were distributed nationwide. All lots within expiration date are affected by this recall.  The product was distributed nationwide, Bermuda and Puerto Rico.

This ongoing Class III recall was initiated by Aventis, by letter on February 18, 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-263-0

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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