Jubilant Cadista Pharmaceuticals is recalling one lot of Drospirenone and Ethinyl Estradiol tablets, an estrogen/progestin combination oral contraceptive.
The product is being recalled due to out-of-specification (OOS) dissolution results at the 3-month stability time point.
Product efficacy may be decreased due to incomplete absorption of the active ingredients.
The firm has not received any reports of adverse events to date.
The recalled products are packaged into a carton containing three blister cards. Each blister card contains 28-film coated, biconvex tablets, in the following order: 24 active pink-color round, unscored, film-coated tablets debossed with a “20” on one side, each containing 3 mg Drospirenone and 0.02 mg Ethinyl Estradiol, and four (4) inert white-color round, unscored, film-coated tablets debossed with a “PL”.
The recalled products, with lot number 183222, NDC number 59746-763-43 and expiration date of 11/2020, were shipped to wholesalers, distributors and retailers nationwide.
What to do
Jubilant Cadista Pharmaceuticals is notifying its customers by emailing a recall notification letter and response form and is arranging for return of all recalled products.
Patients who have used the recalled products may return them to the place of purchase.
Consumers with questions may contact Jubilant Cadista at (800) 308-3985 Monday – Friday from 9:00 a.m. – 6:00 p.m. (EDT).