OH, BABY--BIRTH CONTROL PILLS RECALLED; COULD ALLOW PREGNANCIES TO OCCUR

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September 16, 2011 (Washington D.C.) – If you have taken any of the following brands of birth control pills manufactured by Qualitest Pharamaceuticals, you are advised to switch to another, non-hormonal form of birth control immediately and talk to your doctor or pharmacist: Cyclafem, Emoquette, Gildess, Osrythia, Previfem, and Tri-Previfem.

 

These pills have been recalled nationwide by the manufacturer due to an error that could allow women to become pregnant.

 

The oral contraceptives recall is being implemented because of a packaging error, where select blisters were rotated 180 degrees within the card, reversing the weekly tablet orientation and making the lot number and expiry date no longer visible. As a result of this 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.

Pharmacies are being instructed to contact consumers who have received affected product. The source of the error is currently under investigation and the company is committed to rectifying the issue in a timely manner.

 

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®

The affected lot numbers can be found at the following URL: http://www.qualitestrx.com/pdf/OCRecall.pdf

 

Doctors, pharmacists or women seeking additional information on this recall, or consumers who have affected products, should contact Qualitest toll free at 1-877-300-6153 between the hours of 8:00 a.m. and 5:00 p.m. CT Monday through Friday for information or to arrange return of any affected product. The lot numbers can be found on the bottom of the box or the individual blister card.

 

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 either online, by regular mail or by fax.

Online:www.fda.gov/medwatch/report.htm

Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at:
www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form.
Fax: 1-800-FDA-0178

 

Qualitest is a wholly owned subsidiary of Endo Pharmaceuticals (Nasdaq: ENDP), a U.S.-based, specialty healthcare solutions company, focused on high-value branded products, specialty generics and medical devices and services.  www.endo.com.

 


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