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Jubilant Cadista Pharmaceuticals is voluntarily recalling one lot of Drospirenone and Ethinyl Estradiol Tablets because of concerns regarding product efficacy.
Jubilant Cadista Pharmaceuticals, Inc. announced on July 23, 2019 that it was voluntarily recalling one lot of Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/0.02mg, 28x3 Blister Pack/Carton because of out-of-specification dissolution results at the three-month stability time point. The company states that these OOS results may decrease product efficacy because of incomplete absorption of active ingredients.
The affected product, which was distributed nationwide, is identified as lot number 183222, with NDC number 59746-763-43 and expiration date of 11/2020.The company is advising patients that have used the affected lot of to consult their healthcare provider. Patients may return the affected lot to their place of purchase.
Drospirenone and Ethinyl Estradiol tablets are an estrogen/progestin combination oral contraceptive used to prevent pregnancy, treat symptoms of premenstrual dysphoric disorder (PMDD), and treat moderate acne for women at least 14 years old.
According to the company, the recall is being carried out to the consumer level and it has not received any reports of adverse events related to the recall. Adverse events may be reported to FDA via its MedWatch program.