Errors in packaging could cause accidental pregnancies, company warns.
WEDNESDAY, Feb. 1, 2012 (MedPage Today) —
The affected lots of norgestrel and ethinyl estradiol tablets (Lo/Ovral 28 and Norgestrel 0.3 mg/Ethinyl Estradiol 0.03 mg) may include some blister packs with inexact counts of inert and active-ingredient tablets, and tablets that are out of sequence, a statement from Pfizer said.
The packs contain 28 tablets, including 21 with active ingredient and 7 inert tablets, which provide contraception when dispensed in a correct dosing schedule.
The packaging error may place the daily dosing regimen out of order and, as a result, may put patients at risk for unintended pregnancy, the statement said.
Such an error does not pose an immediate health risk, Pfizer added, but patients using the product should switch to a nonhormonal form of birth control.
A full list of affected lot numbers is available in the recall notice, and includes 14 lots of brand-name product and 14 lots of generic product. Patients with an affected product should consult a healthcare professional and return the product to a pharmacy.
The contraceptives were manufactured and packaged by Pfizer and marketed and labeled by Akrimax Rx Products.
Thursday, January 23, 2020