Packaging Error Leads to Recall of Multiple Lots of Oral Contraceptives

Manufacturing Snafu Could Leave Women at Risk for Pregnancy

September 20, 2011 05:15 pm News Staff

Qualitest Pharmaceuticals, based in Huntsville, Ala., has voluntarily initiated an immediate, nationwide recall of multiple lots of oral contraceptives(www.fda.gov) because of a packaging error that affects the products' dosing regimen and could increase a woman's risk of becoming pregnant.

Specifically, blister packs on the medications were rotated 180 degrees during the manufacturing process, reversing the weekly tablet orientation and rendering the lot number and expiration date no longer visible. As a result of the error, the daily dosing regimen for these medications may be incorrect, leaving women who use them without adequate contraception and, thus, at risk for pregnancy.

Although the packaging defects do not represent any direct health risks, women who have been using these products should immediately begin using a supplemental, nonhormonal form of birth control and contact their physician right away. Pharmacies are being instructed to contact women who have received affected product.

The exact products covered in the recall are

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

The affected lot numbers(www.qualitestrx.com) are listed on the Qualitest website.

Clinicians, pharmacists or women seeking additional information on this recall, as well as women who have affected product, can contact Qualitest toll-free at (877) 300-6153 between the hours of 8:00 a.m. and 5:00 p.m. CDT Monday through Friday for information or to arrange return of any affected product.

Adverse reactions or quality problems associated with the use of these products may be reported to Qualitest at the number shown above or to the FDA's MedWatch Adverse Event Reporting program(www.accessdata.fda.gov).


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