The FDA says patients could be taking a "placebo instead of an active tablet," which can result in pregnancy.

By Robyn Merrett
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Apotex Corp

The U.S. Food and Drug Administration has announced a nationwide birth control recall as a result of a packaging error.

Apotex Corporation has recalled four lots of Drospirenone and Ethinyl Estradiol Tablets due to incorrect tablet arrangements or empty blister pockets.

Because of the error, women may find themselves mistakingly missing a pill or taking a placebo instead of an active pill, which can result in pregnancy.

“As a result of this packaging error, where a patient does not take a tablet due to a missing tablet or that patient takes a placebo instead of an active tablet, loss of efficacy is possible due to variation in the dosage consumed,” read a statement on the FDA’s website.

“The four recalled lots of Drospirenone and Ethinyl Estradiol Tablets, USP may possibly contain defective blisters with incorrect tablet arrangement and/or an empty blister pocket.”

At this time, no “case has been reported for pregnancy and adverse event to Apotex.”

Apotex Corp

However, the FDA is urging those with questions to contact their local pharmacy.

“Individuals should not interrupt their therapy, use a non-hormonal method of birth control, contact their health care provider for medical advice and may return the impacted packages to their pharmacist,” the FDA.

According to the FDA, “Drospirenone and ethinyl estradiol tablets consist of 28 film-coated, biconvex tablets in the following order: 21 yellow color tablets, each containing 3 mg drospirenone (DRSP) and 0.03 mg ethinyl estradiol (EE), and 7 placebo white color tablets.”

The affected lots, which have been distributed nationwide, are 7DY008A, 7DY009a, 7DY010, 7DY011A.

The FDA is urging any patient with questions to call Apotex Corp. at 1-800-706-5573.

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