Pfizer has voluntarily recalled 14 lots of Lo/Ovral-28 and 14 lots of Norgestrel and Ethinyl Estradiol tablets in the US due to possibility of inexact tablet counts or out of sequence tablets.
The products are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. The products are packaged in blister packs containing 21 tablets of active ingredients and seven tablets of inert ingredients.
As a result of the 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. The cause was identified and corrected immediately, the company said. The tablets were manufactured and packaged by Pfizer, commercialized by Akrimax Rx Products and labeled under the Akrimax Pharmaceuticals brand.
