NEWS | Sept. 20, 2011

Qualitest Pharmaceuticals recalls oral contraceptives

By Jeff Kelly Naval Health Clinic Charleston public affairs officer

Based on recommendations issued Sept. 16 from the U.S. Food and Drug Administration, Naval Health Clinic Charleston is recalling different lots of Qualitest Pharmaceutical oral contraceptives. The recall includes Cyclafem 7/7/7, Cyclafem 1/35, Emoquette, Gildess FE 1.5/30, Gildess FE 1/20, Orsythia, Previfem and Tri-Previfem.

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 expiration date no longer visible.

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

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

· 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