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In March 2019, Apotex Corp. voluntarily recalled drospirenone and ethinyl estradiol tablets. This recall affects four lots of drospirenone and ethinyl estradiol 3 mg/0.03 mg 3-count blister card packages (NDC 60505-4183-3; Lot # 7DY008A, 7DY009A, 7DY010A, 7DY011A). The NDC on the individual blister cards is 60505-4183-1. Recalled products may contain empty blister pockets or incorrect tablet arrangements.
Drospirenone and ethinyl estradiol tablets are an oral contraceptive used to prevent pregnancy. As a result of this error, if a patient fails to take a tablet due to an absent tablet or takes a placebo tablet instead of an active tablet, unintended pregnancy may occur.
Consumers with questions can call Apotex Corp. via phone at 1-800-706-5575 or email at UScustomerservice@Apotex.com. Consumers should report any adverse reactions experienced from this product to their provider and the FDA MedWatch Adverse Event Reporting Program online at www.fda.gov/medwatch/report.htm.
Additional information:
- MedWatch Safety Alert – March 4, 2019
www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm632629.htm - Apotex Corp. press release – March 4, 2019
www.fda.gov/Safety/Recalls/ucm632629.htm