Pfizer, Akrimax, and the FDA have notified healthcare professionals and patients that they are recalling 14 lots of Lo/Ovral-28 (norgestrel and ethinyl estradiol tablets) and 14 lots of generic norgestrel and ethinyl estradiol tablets. 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.
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. Lo/Ovral-28 should contain 21 tablets of active ingredients and seven tablets of inert ingredients.
Healthcare providers who have the affected product in their possession should quarantine them for return. A full list of the affected lots can be found at www.fda.gov/Safety/Recalls/ucm289770.htm.
For more information, visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm289803.htm.