Pfizer Inc. announced today that it has voluntarily recalled 14 lots of Lo/Ovral®-28 (norgestrel and ethinyl estradiol) Tablets and 14 lots of Norgestrel and Ethinyl Estradiol Tablets (generic), oral contraceptives.
An investigation by Pfizer found that some blister packs of the pills 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. 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 and return the product to the pharmacy.
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 or to FDA’s Med Watch Program at www.fda.gov/medwatch/report.htm.
For a full list of affected lots, please visit www.fda.gov/Safety/Recalls/ucm289770.htm.
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