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."
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