ALERT: Birth Control Pill Recall

SUMMARY: A voluntary recall on oral contraceptives manufactured by Qualitest Pharmaceuticals is underway, due to a packaging error that has the potential for incorrect use resulting in unintended pregnancy.

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A packaging error on oral contraceptives by Qualitest Pharmaceuticals has led to a voluntary recall. Qualitest, a manufacturer of generic pharmaceuticals, announced that mis-packaging on some birth control pills may cause the contraceptive regimen to be incorrect and may result in unintended pregnancy.

The blister pack on several brands of Qualitest contraceptives was accidentally rotated 180 degrees, reversing the orientation of the pills, with the potential for incorrect use. This may cause the hormone-based pill to fail. Additionally, the labeling mistake resulted in the expiration date being hidden.

There are no health risks associated with the recall, other than lack of protection from pregnancy. Patients who are currently taking the affected product should use non-hormonal contraception and consult their doctor about the issue.

The recalled products include:

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

For a complete list of affected lot numbers, you can go to: http://www.qualitestrx.com/pdf/OCRecall.pdf

Adverse reactions or quality problems experienced with the use of these products may be reported to Qualitest toll free at 1-877-300-6153 or to the FDA's MedWatch Adverse Event Reporting program www.fda.gov/medwatch/report.htm.