Pfizer Inc. announced this week that it has voluntarily recalled 14 lots of Lo/Ovral®-28 (norgestrel and ethinyl estradiol)birth control tablets and 14 lots of Norgestrel and Ethinyl Estradiol birth control tablets (generic) for customers in the U.S. market. An investigation by Pfizer found that some blister packs may contain an inexact count of inert or active ingredient tablets and that the tablets may be out of sequence. The cause was identified and corrected immediately.
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. This product is distributed to warehouses, clinics and retail pharmacies nationwide.
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. These packaging defects do not pose any immediate health risks. However, 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.
These products are packaged in blister packs containing 21 tablets of active ingredients and seven tablets of inert ingredients. Correct dosing of this product is important in avoiding the associated risks of an unplanned pregnancy.
Any adverse events that may be related to the use of these products should be reported to Akrimax Medical Information at 1-877-509-3935, 8 a.m. to 7 p.m., Monday through Friday, CST.
Pfizer has responded rapidly to ensure that its products continue to meet the company's high quality standards.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Lot numbers of affected packs of Lo/Ovral®-28 (norgestrel and ethinyl estradiol) tablets and Norgestrel and Ethinyl Estradiol tablets (generic) can be found at http://www.fda.gov/Safety/Recalls/ucm289770.htm