Pfizer Recalls Several Lots of Two Oral Contraceptive Products

February 9, 2012 10:58 AM

Pfizer Inc recalled 14 lots of Lo/Ovral-28® (norgestrel and ethinyl estradiol) tablets and 14 lots of norgestrel and ethinyl estradiol tablets (generic) due to potential for inexact count and out-of-sequence tablets, as reported in a Food and Drug Administration (FDA) Drug Safety Communication. A Pfizer investigation found that some blister packs of the affected products may contain an inexact count of inert or active ingredient tablets and that the tablets may be out of sequence. 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. FDA advises that patients who have the affected product should notify their physician and return the product to the pharmacy. A Pfizer press release includes a list of the affected products and indicates the national drug code number, lot number, and expiration date for each. FDA reminds health care providers and patients that they can report any adverse events or side effects related to the use of these products to FDA's MedWatch Safety Information and Adverse Event Reporting Program using the online form, or by following the instructions for submitting a report by mail or fax.