Drug Safety Alerts

Apotex Drospirenone and Ethinyl Estradiol 3 mg/0.03 mg Tablets Patient-Level Recall

03/01/2019

On March 1, 2019, Apotex Corp issued a patient-level recall of drospirenone and ethinyl estradiol tablets.This recall was issued because affected product may possibly contain defective blisters with incorrect tablet arrangements and/or an empty blister pocket.

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. To date, no case has been reported for pregnancy and adverse event to Apotex.

A complete list of the affected lot numbers is provided here.

Patients who have received impacted lots of drospirenone and ethinyl estradiol tablets, USP 3MG/0.03MG or have questions regarding this recall should contact their 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.

Drospirenone and ethinyl estradiol tablets, USP are an estrogen/progestin COC indicated for use by women to prevent pregnancy. Drospirenone and ethinyl estradiol tablets (inner carton) consists 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.

CVS Caremark Response:

This product is not carried by the CVS Caremark Mail Service Pharmacies.

For more information about this recall, please contact Apotex at 1‑800-706-5575, Monday through Friday, 8:30 am to 5:00 pm (ET). You may also contact the U.S. Food and Drug Administration (FDA) consumer inquiry line at 1-888-INFO-FDA (1-888-463-6332) or visit https://www.fda.gov.