Qualitest Pharmaceuticals Oral Contraceptives Recall

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Qualitest Pharmaceuticals Oral Contraceptives: Recall – Packaging Error

includes Cyclafem 7/7/7, Cyclafem 1/35, Emoquette, Gildess FE 1.5/30, Gildess FE 1/20,  Orsythia, Previfem, Tri-Previfem

 

AUDIENCE: Consumer, Pharmacy, OB/GYN

ISSUE: Qualitest Pharmaceuticals issued a 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. 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.

BACKGROUND: These packaging defects do not pose any immediate health risks. Pharmacies are being instructed to contact consumers who have received affected product.

RECOMMENDATION: Consumers exposed to affected packaging should begin using a non-hormonal form of contraception immediately and consult their health care provider or pharmacist. Consumers who have affected products should contact Qualitest for information or to arrange return of any affected product.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the Press Release, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm272237.htm

 

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