Has your birth control been recalled?

Pfizer Inc. announces voluntary nationwide recall of birth control pills. Pfizer recalled 14 lots of Lo/Ovral®-28 (norgestrel and ethinyl estradiol) Tablets and 14 lots of Norgestrel and Ethinyl Estradiol Tablets (generic) for customers in the U.S. market.

Lot numbers of affected packs of Lo/Ovral®-28 (norgestrel and ethinyl estradiol)Tablets and Norgestrel and Ethinyl Estradiol Tablets (generic) follow on the table below:

An investigation found some blister packs may contain an inexact count of inert or active ingredient tablets and the tablets may be out of sequence. Although, 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, 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 (lot numbers are provided above) 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. Correctly packaged blister packs are pictured here.

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 AM to 7 PM Mon-Fri CST) or to FDA's Med Watch Program either online, by regular mail or by fax.