Pharmacy Services Alerts
Drospirenone and Ethinyl Estradiol Product Recall - Missing/Incorrect Tablet Arrangement
Mar 5, 2019 12:00 PM
**Due to an update in May 2019 to the FDA.gov website, provided links may not appropriately redirect. Please visit www.fda.gov/drugs/drug-safety-and-availability to see the most recent FDA Medication Safety Alerts and Safety Communications or to search for specific alerts or communications.**
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.
- MedWatch Safety Alert – March 4, 2019
- Apotex Corp. press release – March 4, 2019