Qualitest Pharmaceuticals, an oral contraceptive manufacturer, has announced a recall of several varieties of birth control pills due to a packaging error that may be affecting users' dosage schedules.
In the affected birth control pill packages, the card used to track dosage is misaligned and may result in women taking the hormone-free filler pills on days when they should be taking active pills. Select blisters were rotated 180 degrees within the card, reversing the weekly tablet orientation and making the lot number and expiry date no longer visible, a Food and Drug Administration (FDA) statement explains.
These packaging defects do not pose any immediate health risks, the statement continues. Consumers exposed to affected packaging should begin using a non-hormonal form of contraception immediately and consult their health care provider or pharmacist.
Qualitest Pharmaceuticals spokesperson Kevin Wiggins reiterated that absence of health risk to women taking the pills. The unintended consequence of pregnancy is really the issue, spokesman Kevin Wiggins said in a statement to CNN. That's why the company took a drastic action.
The recall affected the following products:
Gildess FE 1.5/30
Gildess FE 1/20
The affected lot numbers can be found here.
As of Saturday, Sept. 17, Qualitest had removed the pages on their Web site dedicated to the recall. The above link was salvaged from a Med Page Today article.
The phone number 1-877-300-6153 was previously listed as a hotline for customers to answer questions, arrange to return their pills or report problems. IBTimes was not able to reach a representative on Saturday, Sept. 17, but all pharmacies who distributed these pills were reportedly briefed on the situation, so affected customers should be able direct questions and concerns to their individual pharmacist.
Wiggins told CNN that recall affects 1.4 million packages of birth control that have been distributed since last year.
Oral contraceptives are the most popular form of birth control in the U.S., with a usage estimate upwards of 12 million women.