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http://www.businessweek.com/news/2012-02-11/pfizer-recalls-1-million-birth-control-packs-on-wrong-dosage.html

Bloomberg News

Pfizer Recalls 1 Million Birth-Control Packs on Wrong Dosage

February 11, 2012

(Updates with share price in the eighth paragraph.)

Feb. 1 (Bloomberg) -- Pfizer Inc., the world’s biggest drugmaker, recalled 1 million birth-control packs after discovering that pills were mixed up inside the packages, possibly putting women at risk for unintended pregnancies.

The company recalled 14 lots of Lo/Ovral-28 tablets and 14 lots of a generic version of the medicine, New York-based Pfizer said yesterday in an e-mail. About 1 million packs of 28 tablets were withdrawn, Grace Ann Arnold, a Pfizer spokeswoman, said in a separate e-mail.

The pills, manufactured and packaged by Pfizer, were marketed by closely held Akrimax Rx Products of Cranford, New Jersey under the Akrimax Pharmaceuticals brand. The company hasn’t received any reports of adverse health consequences, Arnold said.

Each pack contains 21 white tablets that contain the synthetic hormones norgestrel and ethinyl estradiol and are taken for 21 consecutive days. The remaining seven tablets are inactive pink pills taken for a week.

“An investigation by Pfizer found that some blister packs may contain an inexact count of inert or active ingredient- tablets and that the tablets may be out of sequence,” the company said. That could cause women to take an incorrect daily dosage and increase the risk of accidental pregnancy.

The error was “identified and corrected immediately,” and doesn’t pose immediate health risks, Pfizer said. “However, consumers exposed to affected packaging should begin using a non-hormonal form of contraception immediately.”

Wyeth Pharmaceuticals won FDA approval of Lo/Ovral-28 in 1976. Watson Pharmaceuticals Inc. is among companies that offer generic copies. Pfizer acquired Wyeth in 2009.

Pfizer rose less than 1 percent to $21.31 at 4 p.m. New York time.

--Editors: Andrew Pollack, Stephen West

To contact the reporter on this story: Molly Peterson in Silver Spring, Maryland at mpeterson9@bloomberg.net

To contact the editor responsible for this story: Adriel Bettelheim at abettelheim@bloomberg.net.


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