Description: This recall involves 14 lots of Lo/Ovral®-28 (norgestrel and ethinyl estradiol) tablets and 14 lots of Norgestrel and Ethinyl Estradiol Tablets (generic). These products are oral contraceptives indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. These tablets were manufactured and packaged by Pfizer Inc., commercialized by Akrimax Rx Products and labeled under the Akrimax Pharmaceuticals brand.
Hazard: An investigation by Pfizer found that some packets may contain an inexact count of inert or active ingredient tablets and that the tablets may be out of sequence. These packaging defects do not pose any immediate health risks; however, the daily regimen for these oral contraceptives may be incorrect and could leave women without adequate contraception, and at risk for unintended pregnancy.
Remedy: Consumers exposed to affected packaging should begin using a non-hormonal form of contraception immediately. Patients who have the affected product should notify their physician and return the product to the pharmacy.