According to a statement issued on the US Food and Drug Administration website, September 16, 2011 a pharmaceutical company has issued a voluntary recall for multiple lots of an oral contraceptive, at the retail level, effective immediately.
The contraceptives have been recalled by Qualitest Pharmaceuticals, a generic drugmaker from Alabama, because a number of lot numbers and expiration dates are not visible due to a packaging error.
The recalled oral contraceptives had a blister that had been turned 180 degrees on the card it was packed on, resulting in a reversal of the weekly tablet orientation and obscurity of the expiration date and lot number, the company said.
This packaging error and the potential for this error to have affected other oral contraceptive products resulted in the company issuing the recall of multiple lots.
A Qualitest spokesperson warned that the affected products might not protect the woman from pregnancy. The statement issued stated, “As a result of this packaging error, the daily regimen for these oral contraceptives may be incorrect and could leave women without adequate contraception, and at risk for unintended pregnancy.”
Company spokesman Kevin Wiggins, said “There are no immediate health issues currently. The unintended consequence of pregnancy is really the issue. That’s why the company took a drastic action.”
Normally, birth control pills are packaged so that it is easy to see what order the pills should be taken in, but in about 1.4 million Qualitest packs, the orientation was reversed and the pills’ lot numbers and expiration dates were not visible.
The orientation matters because four or seven pills each month are placebos, so that the woman can have her menstrual period. The placebos are supposed to be taken at the end of the month, but in the defective Qualitest packs, they were placed at the beginning.
“The worst pill to miss in any pack of pills is the very first pill,” Marjorie Greenfield, the division chief of obstetrics and gynecology at University Hospitals Case Medical Center in Cleveland, Ohio, told ABC News. “And so now you’re missing the first four or the first seven, so you will probably release an egg that month.”
That means the risk of unintended pregnancy for women who used the defective packs was “substantive,” Greenfield said. When used correctly, birth control pills are between 96 and 99 percent effective, but taking pills at different times of the day or skipping days decreases their effectiveness drastically. “Missing pills is a way that can totally fail,” she said. “Not that it fails a little — it totally fails when you miss a few pills.”
The following is a list of the products that have been recalled:
Gildess FE 1/20
Gildess FE 1.5/30
Qualitest says it is liaising with authorities at a very high level, as well as manufacturers to find out why the error occurred.
The company, as well as the FDA, would like you to know if you have been using any of the affected products, make sure you use a non-hormonal contraception and check with a health care professional. Pharmacies are being instructed to contact consumers who have received affected product.
For additional information on this recall or to report adverse events or arrange return of affected product, contact Qualitest toll free at 1-877-300-6153 between the hours of 8:00 a.m. and 5:00 p.m. CST, Monday through Friday.
Adverse events or quality problems related to this recall may also be communicated to MedWatch, the FDA’s safety information and adverse event reporting program.