From Our 2012 Archives
1 Million Birth Control Pill Packs Recalled
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Pregnancy Risk With Lo/Ovral-28, Generic Norgestrel/Ethinyl Estradiol
By Daniel J. DeNoon
Reviewed by Laura J. Martin, MD
Feb. 1, 2012 -- Pfizer has recalled 1 million packs of Lo/Ovral-28 and generic norgestrel/ethinyl estradiol birth control pills.
The pills, which must be taken in the correct sequence, may be mixed up. Women using the products risk pregnancy and should consult their doctors.
Although the pills are made and packaged by Pfizer, they are sold by Akrimax Rx Products and carry the Akrimax name on their labels.
The recall includes 14 lots of brand-name birth control pills and 14 lots of generic birth control pills distributed across the U.S.
The pills come in blister packs of 28 pills from which each dose must be taken in sequence. A Pfizer investigation found that some packs have the wrong number of pills, and the pills may be out of order.
Each pack normally contains 21 white pills with an active ingredient and seven pink pills that are inert. But women who take inert pills on days they should be taking active ones may not get the contraceptive effect they want, and should be aware of the signs of early pregnancy.
Other than pregnancy, the recalled pills have no health risks other than those usual for the product.
Pfizer has corrected the error. Meanwhile, the following product lots are being recalled:
Women who have used the products should notify their doctors and return the products to their pharmacies.
SOURCES: News release, FDA.News release, Pfizer.
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