Birth-Control Recall: Qualitest Pharmaceuticals Pulls Pills Because of Packaging Mistake

Sept. 16, 2011 — -- Women who are taking birth-control pills by Qualitest Pharmaceuticals should get in touch with their physicians immediately in the wake of a company recall because of a packaging error, doctors recommend.

Dr. Ranit Mishori, an assistant professor in the department of family medicine at Georgetown University, said today that patients should ask for an alternate product and use an additional means of contraception.

"They may want to get a pregnancy test [as well]," said Mishori, adding that she did not prescribe Qualitest products.

The voluntary recall affects eight kinds of birth-control pills -- including a variety of generic brands such as Cyclafem, Emoquette, Gildess, Orsythia, Previfem and Tri-Previfem -- and an estimated 1.4 million packs of pills that started getting shipped out last year.

Qualitest said the error caused the weekly tablet orientation to be reversed and obscured the pills' lot numbers and expiration dates on certain packages. None of the recalled pills has expired.

Qualitest: 2% of Oral Contraceptive Market

Qualitest accounted for about 2 percent of the oral contraceptive market, a spokesman for the Huntsville, Ala., company said.

Birth-control pills, which contain estrogen and progesterone, prevent the release of an egg by fooling the body to believe it has already done so. The first three weeks of pills provide the hormones in varied or similar doses and the last four or seven pills of a pack -- usually of a different color -- contain nothing so that a women can get her menstrual period.

Dr. Marjorie Greenfield, division chief of general obstetrics and gynecology at University Hospitals Case Medical Center in Cleveland, said the inactive pills that usually appeared at the end of a package were now at the beginning.

"The worst pill to miss in any pack of pills is the very first pill," she said. "And so now you're missing the first four or the first seven so you will probably release an egg that month."

Greenfield said that in those patients who started with the empty pills, there was a "substantive chance of getting pregnant."

She said, however, that experienced birth-control pill users should notice quickly that the first week in a recalled package was of a different color.

"Missing pills is a way that can totally fail," Greenfield said. "Not that it fails a little, it totally fails when you miss a few pills."