Recall: Birth-control pill packaging error poses pregnancy risk

Consumer Reports News: September 19, 2011 10:08 AM

Qualitest Pharmaceuticals has issued a nationwide recall of an oral contraceptive sold under several product names. A packaging error gives the wrong daily-use instructions, leaving women at risk for unintended pregnancy.

Affected products have a blister packaging that was rotated 180 degrees within the card, reversing the weekly tablet orientation, as well as making the lot number and expiration date no longer visible.

It is not clear from the U.S. Food and Drug Administration's recall notice how many pill packages are affected by the recall, only that "multiple lots of the oral contraceptive" made by Qualites Pharmaceuticals was recalled.

The recalled products include the following:

Cyclafem 7/7/7
Cyclafem 1/35
Emoquette
Gildess FE 1.5/30
Gildess FE 1/20
Orsythia
Previfem
Tri-Previfem

Pharmacies are being instructed to contact consumers who have received the recalled birth control pills.

Consumers who purchased pills with the misleading packaging should immediately begin using a non-hormonal form of contraception and consult their health care provider or pharmacist. Consumers who have affected products should contact Qualitest for information or to arrange return of any affected product.

The affected lot numbers can be found at the following URL: https://www.qualitestrx.com/pdf/OCRecall.pdf. Doctors, pharmacists or women seeking additional information on this recall, or consumers who have affected products, can call Qualitest at 877-300-6153.

Qualitest Pharmaceuticals Oral Contraceptives: Recall - Packaging Error [FDA]

—Maggie Shader