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."
Source:http://edition.cnn.com/2011/09/16/health/birth-control-recall/index.html
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