One million packets of birth control pills are being recalled because of a manufacturing error that may cause a change in the daily regimen, thus putting women at risk for unintended pregnancy.
The recall involves 14 lots of Lo/Ovral-28 (norgestrel and ethinyl estradiol) Tablets and 14 lots of generic Norgestrel and Ethinyl Estradiol. The pills were manufactured and packaged by Pfizer and labeled under the Akrimax Pharmaceuticals brand. They were distributed to warehouses, clinics and pharmacies nationwide. A list of lot numbers can be found on the Pfizer website.
An investigation by Pfizer found that some of the blister packs may contain an inexact count of inert or active ingredient tablets and that the tablets may be out of sequence. These products are packaged in blister packs containing 21 tablets that contain the active ingredient and seven “dummy pills” that contain no active ingredient. Correct dosing of this drug is important in order to prevent unintended pregnancy.
The cause of the manufacturing error was identified and has been corrected. While this problem does not pose a health risk for women who used the pill, it could put them at risk of becoming pregnant. Women who have been using the recalled pills should begin using a non-hormonal form of contraception immediately, and notify their doctors with questions.
Any problems associated with using this pills, such as pregnancies or miscarriages, should be reported to the Food and Drug Administration (FDA) MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/report.htm.