WEDNESDAY, Feb. 1 (HealthDay News) -- About one million packets
of birth control pills are being recalled in the United States by
Pfizer Inc. because of a packaging error that could reduce the
effectiveness of the pills and cause unintended pregnancies.
The recall of 14 lots of Lo/Ovral-28 tablets and 14 lots of
generic Norgestrel and Ethinyl Estradiol tablets was announced late
Tuesday after Pfizer discovered that some blister packs may contain
either too many or too few active pills and that the pills may be
out of sequence. The expiration dates on the recalled packets range
between July 31, 2013 and March 31, 2014.
The pills are packaged in blister packs containing 21 active
tablets and seven inactive tablets. The packaging error means that
the daily regimen for the pills may be incorrect and could leave
women without adequate contraception and at risk for unintended
pregnancy, Pfizer said in a news release.
Experts said the error could pose real problems for women using
the pills.
"This is extremely important," said Dr. Steven Goldstein, professor of obstetrics and gynecology at NYU Langone School of Medicine in New York City. "It is absolutely essential that birth control pills be taken as intended, with 21 medicated pills in a row. Otherwise ovulation could take place and an unintended pregnancy is definitely a possibility."
Another expert agreed.
"Sequence and content of active versus inactive pills is crucial in determining efficacy, including whether or not unwanted pregnancy will be actually prevented," said Dr. Jill Rabin, chief of ambulatory care, obstetrics and gynecology, head of urogynecology at Long Island Jewish Medical Center in New Hyde Park, N.Y.
She said that women who determine that they do have the recalled
contraceptive pills should first "ensure that you are not currently
pregnant (by taking a pregnancy test) if you have any symptoms of
pregnancy (missed periods/abnormal bleeding, etc)." They should
also switch immediately to a non-hormonal form of contraception if
they are not pregnant, notify their health care provider of the
situation, and return the defective product to the pharmacy.
Pfizer has informed the U.S. Food and Drug Administration about
the recall. In a statement issued Wednesday, the FDA agreed that
"patients who have the affected product should notify their
physician and return the product to the pharmacy."
The cause of the error was identified and corrected immediately,
according to Pfizer.
The birth control pills were manufactured and packaged by Pfizer
and sold under the Akrimax Pharmaceuticals brand. The pills were
distributed to warehouses, clinics and retail pharmacies across the
United States.
More information
Here's where you can find more details on
lot numbers and other information on pills inc...ed
in the recall.