Recalls

1.4 million lots of birth control pills recalled for packaging error

Qualitest Pharmaceutials, an Alabama pharmaceutical company, has recalled multiple lots of birth control pills because of a packaging error that could leave women without adequate contraception and at risk for unintended pregnancy. The nationwide retail-level recall was implemented because select blisters were rotated 180 degrees within the card, which reversed the weekly tablet orientation and altered the daily regimen. This also made the lot number and expiration date no longer visible.

The error was first identified by a pharmacist who then reported the problem to Qualitest Pharmaceuticals. The recall affects 1.4 million packages that have been distributed since last year. The following brands are affected: Cyclafem 7/7/7; Cyclafem 1/35, Emoquette, Gildess FE 1.5/30; Gildess FE 1/20; Orsythia; Previfem; Tri-Preifem.

While there are no immediate health risks, Qualitest says women who are using the affected birth control pills should also start using a non-hormonal form of contraception immediately and consult their doctor or pharmacist. Pharmacists have also been asked to contact customers who have received the recalled oral contraceptives.

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 and specific lot numbers are also available at Qualitest birth control pill recall list.

Qualitest says it is working with authorities as well as the products’ manufacturers to determine what may have caused the error. Meanwhile, any side effects with this or any drug should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.

Source: FDA