Qualitest Oral Contraceptives Recalled

Megan Brooks

Disclosures

September 16, 2011

September 16, 2011 — Qualitest Pharmaceuticals, a wholly owned subsidiary of Endo Pharmaceuticals, has voluntarily recalled multiple lots of oral contraceptives, according to a company statement posted on the US Food and Drug Administration's Web site.

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 complete list of the affected lot numbers can be found on the Qualitest Web site. The lot numbers can be found on the bottom of the box or the individual blister card.

Packaging Error

According to the company, the recall was prompted by a packaging error in which 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.

"As a result of the packaging error, the daily regimen for these oral contraceptives may be incorrect and could leave women without adequate contraception, and at risk for unintended pregnancy," the company notes.

The source of the error is currently under investigation.

"These packaging defects do not pose any immediate health risks. However, consumers exposed to affected packaging should begin using a non-hormonal form of contraception immediately and consult their health care provider or pharmacist," the company states.

Pharmacies are being instructed to contact consumers who have received affected product.

For additional information on this recall or to report adverse events or arrange return of affected product, contact Qualitest toll free at 1-877-300-6153 between the hours of 8:00 a.m. and 5:00 p.m. CST, Monday through Friday.

Adverse events or quality problems related to this recall may also be communicated to MedWatch, the FDA's safety information and adverse event reporting program, by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch or by mail to MedWatch, FDA, 5600 Fishers Lane, Rockville, Maryland 20852-9787.

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