An Alabama pharmaceutical company issued a voluntary nationwide recall Friday for « multiple lots » of birth control pills due to what it described as a systemic « packaging error. »
A spokesman for Qualitest Pharmaceuticals said that « there are no immediate health issues currently » because of the packaging problems. Rather, he said, the chief concern is that women may unintentionally become pregnant after taking the oral contraceptive.
« The unintended consequence of pregnancy is really the issue, » spokesman Kevin Wiggins said. « That’s why the company took a drastic action. »
Wiggins said the recall involves 1.4 million packages that have been distributed to pharmacists and customers since last year.
According to a statement for the Huntsville-based company, « select blisters (found inside the pill box) were rotated 180 degrees within the card, reversing the weekly tablet orientation. » This helped to leave the pills’ lot number, as well as the expiration date, « no longer visible. »
« 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 unwanted pregnancy, » the company said.
A pharmacist noticed the issue and contacted the company by phone, Wiggins explained.
Qualitest urged those with such products to begin using a « non-hormonal » form of birth control and consult a health care provider or pharmacist. Pharmacies have been told to contact those who have gotten the faultily packaged pills.
The recall affects these products: Cyclafem 7/7/7, Cyclafem 1/35, Emoquette, Gildess FE 1.5/30, Gildess FE 1/20, Orsythia, Previfem and Tri-Previfem.
Customers can call 1-877-300-6153 between 8 a.m. and 5 p.m. CT to get their questions answered, arrange to return their pills or report problems. Information is also available at http://www.qualitestrx.com/pdf/OCRecall.pdf.
Wiggins said Qualitest is working with authorities « at a very high level, » as well as with the product’s manufacturers, to determine what happened.
« We’re dedicated to ensuring the safe use of our products, (and) this recall reaffirms our high standards, » he said. « It’s an error, nonetheless, and we put patients at the center of what we do. »
CNN.com
