On Thursday Qualitest Pharmaceuticals issued a voluntary and nationwide retail-level recall of multiple lots of oral contraceptives, the U.S. Food and Drug Administration said today.
The recall is being implemented because of a packaging error, where select blisters were rotated 180 degrees within the card, reversing the weekly tablet orientation and making the lot number and expiration date no longer visible.
The 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.
As a result of the problem, the daily regimen for these oral contraceptives may be incorrect and could leave women without adequate birth control and at risk for unintended pregnancy, officials said.
The packaging defects do not pose any immediate health risks, but consumers exposed to affected packaging should begin using a non-hormonal form of contraception immediately and consult their health care provider or pharmacist, the FDA said.
Pharmacies are being instructed to contact consumers who have received recalled product, which include:
- Cyclafem 7/7/7
- Cyclafem 1/35
- Gildess FE 1.5/30
- Gildess FE 1/20
The affected lot numbers can be found at www.qualitestrx.com/pdf/OCRecall.pdf1
Doctors, pharmacists or consumers looking for additional information on this recall, or consumers who have affected products should contact Qualitest at 1-877-300-6153. Lot numbers can be found on the bottom of the box or the individual blister card.