Check your medicine cabinet right now. The U.S. Food and Drug Administration recently issued a major birth control recall for four lots of Drospirenone and Ethinyl Estradiol Tablets, USP. Due to a packaging error, users of these birth control pills could miss tablets or accidentally take a placebo instead of an active tablet. So if you use this product, and take it incorrectly due to the packaging problem, you could get pregnant.
A representative from the pharmaceutical manufacturer, Apotex Corp., told Red Tricycle in an emailed statement, “Apotex is committed to product quality and patient safety and takes all steps necessary to protect patients who use our products. Thus, this voluntary recall was initiated out of an abundance of caution.” Read on for more information on the recall and what you should do about it.
Recalled Birth Control Description
The current recall is only for Apotex Corp.’s Drospirenone and Ethinyl Estradiol Tablets, USP 3MG/0.03MG, manufactured by Oman Pharmaceutical Products Co. LLC. Oman under the subcontract from Helm AG, Germany.
This estrogen/progestin birth control includes 28 film-coated, biconvex tablets. There are 21 active yellow tablets and 7 white placebo tablets in each pack.
Why the Birth Control Was Recalled
The recalled packages may have an incorrectly ordered pill arrangement or empty blister pockets. This error could result in women missing active birth control pills or taking placebos instead pills containing the active ingredients (drospierone and ethinyl estradiol).
A representative from Apotex noted, “No complaints have been received for blisters missing an active tablet or having a placebo instead of an active tablet, and no case has been reported to Apotex for pregnancy.”
How to Tell If Your Birth Control Was Recalled
If you use this product, look for the NDC numbers on the inner and outer cartons. The inner-carton NDC number is 60505-4183-1 and the outer-carton number is 60505-4183-3. The affected lot numbers include 7DY008A, 7DY009A, 7DY010A and 7DY011A.
Visit the FDA’s website here for more information.
What Women Can Do
Anyone using this birth control pill should contact their physician or healthcare provider ASAP. Return the affected products to your pharmacy for a new (non-recalled) pack. If you can’t immediately exchange your affected pill pack for the correct one, or think that you may have missed one or more active pills, use another form of birth control until you talk to your doctor. Missing birth control pills puts you at risk for getting pregnant.
Contact Apotex Corp. by phone at 800-706-5575 between 8:30 a.m. and 5 p.m. ET Monday through Friday. You can also email with company with questions at UScustomerservice@Apotex.com.
—Erica Loop
Photos: Courtesy of U.S. FDA/Featured photo: Ake via Rawpixel
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