Jubilant Cadista Pharmaceuticals is recalling 1 lot of the combination oral contraceptive Drospirenone and Ethinyl Estradiol Tablets, USP, 3mg/0.02mg due to the possibility of decreased product efficacy.
According to the Company, the recall is being initiated because of out-of-specification dissolution test results at the 3-month stability time point. As a result, product efficacy may be reduced due to incomplete absorption of the active ingredient.
Drospirenone and Ethinyl Estradiol tablets are indicated for the prevention of pregnancy, to treat symptoms of premenstrual dysphoric disorder for women who choose to use an oral contraceptive for contraception, and to treat moderate acne for women ≥14 years of age if the patient desires an oral contraceptive for birth control.
The recalled tablets have Lot number 183222, NDC number 59746-763-43, and expiration date of 11/2020. The lot was distributed nationwide to wholesalers, distributors, and retailers. At this time, there have been no reports of adverse events related to this recall; adverse reactions related to the use of this product may be reported to FDA’s MedWatch Adverse Event Reporting program.
For more information call (800) 308-3985 or visit cadista.com.