Recall of Qualitest Oral Contraceptives

On September 15, 2011, Qualitest announced a voluntary recall of several lots of the following oral contraceptives:

Cyclafem 1/35 ™, Cyclafem™ 7/7/7; Emoquette™, Gildess® FE 1.5/30; Gildess® FE 1/20; Orsythia™; Previfem®; and Tri-Previfem®.

The recall is being conducted because a packaging error may have reversed the weekly sequence of pills, resulting in an incorrect daily dose.  This could result in unintended pregnancy.  For more information, please see the FDA release at http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm272237.htm

  • Patients with product from a recalled lot who are using it for contraception are instructed to immediately start using a non-hormonal contraception method (e.g., condom or diaphragm)
  • Patients, providers, and pharmacists with questions may contact Qualitest at 1-877-300-6153 (Monday through Friday from 8:00 AM to 5:00 PM CT).

Information cited from Express Scripts®