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Packaging Error Leads to Recall of Multiple Lots of Oral Contraceptives
Manufacturing Snafu Could Leave Women at Risk for Pregnancy
By News Staff
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,
- Gildess FE 1.5/30,
- Gildess FE 1/20,
- Previfem and
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.