FDA Issues Recall on Oral Contraceptives
September 20, 2011
Last Thursday, the Food and Drug Administration (FDA)
announced the voluntary recall of oral contraceptives made by Qualitest Pharmaceuticals. The nationwide, retail level recall was announced due to packaging errors.
The company announced that certain packs in multiple lots of different oral contraceptives had been printed wrong. The packages were rotated 180 degrees when manufactured, causing the weekly tablet orientation to be reversed and expiration information not visible. The mistake could cause daily regimens to be off, leave women taking the medication at risk for unwanted pregnancies.
While the defects pose no health risks, the agency encourages women taking the drugs to immediately begin use of other forms of contraception and to discuss the mistake with their doctor or pharmacist.
Affected medications include:
• Cyclafem™ 7/7/7
• Cyclafem™ 1/35
• Gildess® FE 1.5/30
• Gildess® FE 1/20
• Previfem ®
Those looking for information on this recall should contact Qualitest toll free at 1-877-300-6153 Monday through Friday to arrange return of any affected product. Adverse reactions or quality problems should also be reported to the FDA’s MedWatch Adverse Event Reporting program.