A nationwide recall has been announced by the FDA for specific birth control pill packages with missing or incorrect tablet increasing the chance of unintended pregnancies.
To date, no unintended pregnancies have been reported to the manufacturer, Apotex Corp. The recall is voluntary and includes four lots of Drospirenone and Ethinyl Estradiol Tablets. The company believes that the lots may possibly contain defective blisters with incorrect tablet arrangements and/or empty blister pockets. As a result of this error, the patient may be missing a tablet or taking a placebo instead of the active tablet. This could reduce the efficacy due to the variation in the dosage.
Those who have received the recalled products should contact their pharmacy with any questions or concerns. Individuals should not interrupt their therapy. It is recommended that the patient uses a non-hormonal method of birth control, contact their health care provider for medical advice, and return the impacted packages to their pharmacist.
Drospirenone and Ethinyl Estradiol Tablets, USP is an estrogen/progestin COC indicated for use by women to prevent pregnancy. Drospirenone and Ethinyl estradiol tablets (inner carton) 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 Drospirenone and Ethinyl Estradiol Tablets, USP lots include the following and can be identified by NDC numbers stated on the inner and outer cartons:
These products were distributed nationwide to wholesalers and distributors. All wholesalers and distributors have been notified by mail by FedEx Standard Overnight. Any retailer with existing recalled lots should quarantine these lots immediately.
Customers who purchased the impacted product directly from Apotex can call GENCO at 1- 877-674-2082 ( – 5:00 pm, CST Monday thru Friday), to arrange for their return.
Consumers with questions regarding this recall can contact Apotex Corp. by phone-number 1-800-706-5575 (8:30 am – 5:00 pm, EST Monday thru Friday) or email address UScustomerservice@Apotex.com . Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
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