While no method of contraception offers a 100 percent guarantee, when taken correctly, the birth control pill comes pretty close at 99 percent. The efficacy of oral contraception depends, primarily, upon how consistently and properly it is used; however, in very rare cases like this, contraceptive failure can be completely out of your control. The U.S. Food and Drug Administration has issued a birth control recall, which they say is due to a packaging error.
Four lots of Drospirenone and Ethinyl Estradiol Tablets are being recalled, whose packages “may possibly contain defective blisters with incorrect tablet arrangements and/or an empty blister pocket.” The packaging mishap means that individuals may miss dosages due to missing pills, or unknowingly take a placebo instead of an active pill, leaving them at risk of unintended pregnancy.
The FDA’s official risk statement is as follows: “As a result of this packaging error, where a patient does not take a tablet due to a missing tablet or that a patient takes a placebo instead of an active tablet, loss of efficacy is possible due to variation in the dosage consumed.” The affected medication is described as: “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” with the following numbers stated on the inner and outer cartons: 7DY008A, 7DY009a, 7DY010, 7DY011A.
Apotex Corporation, the Florida-based pharmaceutical company responsible for the error, has issued the nationwide recall to all wholesalers and distributors. Though no pregnancies have been reported due to this error, it’s certainly a risk. However, don’t panic if you think you’ve been affected by this recall. Instead, The FDA advises that individuals should not discontinue their medication, and instead incorporate a non-hormonal method of birth control as backup, should they want to prevent pregnancy.
Unfortunately, birth control recalls are not uncommon. In May of 2018, Allergan announced it was recalling 168,768 packs of Taytulla, and in 2012, Pfizer recalled nearly 1 million birth control pills — both instances were also due to packaging errors. This is why it’s important to keep a close eye on any prescriptions, making sure the correct amount of medication has been provided to you and that the descriptions on the package match the pills.
Of course, you should always contact your gynecologist with any concerns regarding your birth control or other medications. Anyone with questions about the current birth control recall can also contact Apotex Corp. at 1-800-706-5573.