Glenmark Generics Ltd. in India manufactured the tablets and Glenmark Generics USA distributed them in the United States from Sept. 21 to Dec. 30, officials said.
The recall was implemented because of a packaging error, where select blisters were rotated 180 degrees within the card, reversing the weekly tablet orientation and making the lot number and expiration date visible only on the outer pouch. Any blister for which the lot number and expiration date is not visible is subject to recall.
The seven lots of norgestimate and ethinyl estradiol oral contraceptives include:
-- 04110101, expiration date July 31, 2013.
-- 04110106, expiration date July 31, 2013.
-- 04110107, expiration date July 31, 2013.
-- 04110114, expiration date Aug. 31, 2013.
-- 04110124, expiration date Aug. 31, 2013.
-- 04110129, expiration date Aug. 31, 2013.
-- 04110134, expiration date Sept. 30, 2013.
As a result of the error, the daily regimen for these oral contraceptives may be incorrect and could leave women without adequate contraception, and at risk for unintended pregnancy, Glenmark officials said. The packaging defects do not pose any immediate health risks, but women affected by the error should begin using a non-hormonal form of contraception immediately, officials said.
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