DETROIT (WWJ) - Prescription drug company Pfizer has voluntarily recalled two types of birth control pills.
The recall applies to 14 lots of Lo/Ovral®-28 Tablets and 14 lots of Norgestrel and Ethinyl Estradiol Tablets (generic). 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.
To view a complete list of the affected lots, click here.
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.
The tablets were manufactured and packaged by Pfizer, commercialized by Akrimax Rx Products and labeled under the Akrimax Pharmaceuticals brand. This product was distributed to warehouses, clinics and retail pharmacies nationwide.
Any adverse events that may be related to the use of these products should be reported to Akrimax Medical Information at 877-509-3935 or to FDA’s Med Watch Program.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.