More Birth Control Recalled Due To Packaging Problems

For the third time in six months, a drug maker has recalled birth control pills due to packaging issues, which may expose women to a risk of unwanted pregnancy.

Last week, a nationwide recall for norgestimate and ethinyl estradiol birth control pills was issued by Glenmark Generics, due to a risk that some packages of pills from seven different lots may contain out-of-sequence tablets.

Some blister packs may have been rotated 180 degrees within the card, causing women to take the wrong pills during their cycle. This may leave women without adequate contraception and expose them to a risk of pregnancy.

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In January, Pfizer recalled about one million packs of Lo/orval-28 and generic norgestrel birth control pills due to similar problems, where some blister packs in 28 different lots were identified as potentially containing the wrong number of pills and out of sequence tablets.

A Qualitest birth control pill recall was issued in September 2010, impacting 70 lots Cyclafern, Emoquette, Gildess, Orsythia, Previfem and Tri-Previfem pills, which also contained blister packages that may have been rotated 180 degrees during packaging, reversing the weekly tablet orientation.

Athough there is no immediate health risk from the recalled birth control pills, these production problems could leave women exposed to a risk of unintended pregnancies. In many cases women may be on birth control due to substantial risks associated with becoming pregnant, such as potential health problems the mother may face or a risk of birth defects or malformations that may be caused by other medications the woman may be taking.

The recall issued by Glenmark Generics impacts packs of Norgestimate and Ethinyl Estradiol Tablets USP, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg (Generic). The packages all contain expiration dates of 7/31/2013, 8/31/2013 or 9/30/2013, and contain lot numbers 04110101, 04110106, 04110107, 04110114, 04110124, 04110129 or 04110134.

As a result of a packaging error, where the blisters are rotated 180 degrees within the card, the lot number and expiration date will only be visible on the outer pouch. Therefore, if the lot number or expiration date is covered up, the birth control pills are subject to a recall.

The correct packaging configuration of each pouch pack should contain 28 tablets, in which the sequence is white to off-white tablets on the top row and inactive light green tablets in the bottom row. (The image above contains the correct sequence).


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