Birth Control Recall: Norgestimate and Ethinyl Estradiol Tablets Recalled Over Packaging Errors
For the second time this year, certain birth control medications are being recalled over a packaging error.
Glenmark Generics Inc. has announced a voluntary recall of seven lots of its Norgestimate and Ethinyl Estradiol Tablets USP, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg.
Glenmark Generics explained how the error occurred:
The recall is being 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 expiry date visible only on the outer pouch.
Birth control pills are intentionally packaged in a specific order to provide protection from pregnancy. In these specific recalled pills, 21 tablets contain hormonal compounds to prevent pregnancy, while the last seven tablets don't contain any active ingredients. If a woman takes the pills out of order or takes inactive pills thinking they are active, she may be at risk of pregnancy.
"With birth control pills, if the exact count or sequence is out of order the efficacy of the birth control pill could be significantly decreased. If this is the case, patients may be experiencing irregular bleeding and may be at higher risk for unintended pregnancy," Dr. Adam Jacobs, assistant professor of obstetrics, gynecology and reproductive science at Mount Sinai Medical Center, told Everyday Health.
The company noted that there are no other health risks associated with the recall. [For more information on which lots of the birth control were recalled, click here.] People who find that one of their birth control packs is affected by the recall should tell their doctor and return the birth control to the pharmacy.
Earlier this year, Pfizer announced its recall of 1 million packages of its Lo/Ovral-28 tablets and generic Norgestrel and Ethinyl Estradiol tablets, because some of the birth control tablets may be out of sequence, or there may be more of the active pills in some packages and more inactive pills in other packages.