Apotex Recalls Drospirenone and Ethinyl Estradiol Tablets
March 4, 2019 – Drug manufacturer Apotex Corp has announced a voluntary recall of four lots of Drospirenone and Ethinyl Estradiol 3mg/0.03mg Tablets, which may contain defective blisters with incorrect tablet arrangements and/or an empty blister pocket. The tablets are indicated to provide birth control for women and offer a generic alternative for the brand name drug Yasmin®, from Bayer.
Because of the packaging error, it is possible that women taking the recalled tablets could become pregnant while on the medication by either missing a scheduled dose or taking a placebo pill on a day an active pill should be taken. No adverse events had been reported as of the date of the recall.
Apotex advises affected patients to speak to their healthcare provider. Questions regarding the recall can be directed to Apotex by phone at 1-800-706-5575 (8:30am – 5:00pm EST, Monday – Friday) or by email at UScustomerservice@Apotex.com. Adverse events that may be related to the recalled product should be reported to the patient’s healthcare provider, and can also be reported to the FDA’s MedWatch program.
Further details are available at: https://www.fda.gov/Safety/Recalls/ucm632629.htm
Our mail order facility, Benecard Central Fill did not dispense medications impacted by the recall.