Multiple Lots of Oral Contraceptives Recalled by Qualitest Due to Packaging Error

Qualitest Pharmaceuticals has issued a voluntary, nationwide, retail-level recall of multiple lots of oral contraceptives because a packaging error may result in the daily regimen for these products being incorrect and could leave women without adequate contraception, and at risk for unintended pregnancy. Specifically, the recall is being implemented because of a packaging error, where certain blisters were rotated 180 degrees within the card, reversing the weekly tablet orientation and making the lot number and expiry date no longer visible. This 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. The recall is effective immediately and includes the following products:

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

A list (PDF) of affected lot numbers has been posted on the Qualitest Pharmaceuticals Web site. Lot numbers can be found on the bottom of the box or the individual blister card.

In a press release, Qualitest notes that pharmacies are being instructed to contact consumers who have received affected product. Health care providers or patients seeking additional information on this recall should contact Qualitest by calling 877/300-6153. Adverse reactions or quality problems experienced with the use of these products may be reported to Qualitest by calling 877/300-6153, or to the FDA's MedWatch Adverse Event Reporting program using the online form or by completing and mailing the printed Form FDA 3500 according to the instructions provided.
 

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