Pfizer said it is recalling 28 lots of two kinds of birth control pills because some of the blister packs might contain an inexact count of inert or active ingredients and that the tablets might be out of sequence.
The company said 14 lots of Lo/Ovral-28 (norgestrel and ethinyl estradiol) Tablets and 14 lots of Norgestrel and Ethinyl Estradiol Tablets (generic) were distributed to warehouses, clinics and retail pharmacies in the United States. About one million packets are involved in the recall.
The Pfizer statement said these tablets were manufactured and packaged by Pfizer Inc., marketed by Akrimax Rx Products and labeled under the Akrimax Pharmaceuticals brand.
"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," Pfizer said in its statement. "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 below) 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."
Anyone suffering an adverse event related to the use of these products should report it to Akrimax Medical Information at 1-877-509-3935 (8 a.m. to 7 p.m. Central time, Mon-Fri) or to FDA's Med Watch Program, which can be found online here.
The lot numbers for the packages being recalled can be found on the Pfizer news release, which is here.