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Pfizer Inc. is recalling 1 million packets of birth control pills after uncovering a packaging error that could leave women with an inadequate dose of the hormone-based drugs and raise the risk that they will get pregnant accidentally.
The company writes in a release:
"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. "
The problem affects 14 lots of Lo/Ovral-28 tablets and 14 lots of generic Norgestrel and Ethinyl Estradiol tablets. Both products are manufactured by Pfizer and marketed in the U.S. by Akrimax Rx Products.
Pfizer found that some packets of the drugs had too many active tablets, while others had too few. Oral birth control products use a series of 21 drug tablets and seven inactive sugar tablets to regulate the menstrual period while providing contraception.
A company spokeswoman said the problem was caused by both mechanical and visual inspection failures on the packaging line. She said the problem has been corrected.
The affected packets have expiration dates ranging between July 31, 2013, and March 31, 2014.
The drugs were distributed to warehouses, clinics and retail pharmacies throughout the U.S.
Read the FDA alert here.