Medication Monitor

Generic Name (Trade Name—Company)
August 1, 2019

Drospirenone and ethinyl estradiol tablets

(No trade name—Jubilant Cadista Pharmaceuticals)
Recall affects one lot found to have out-of-spec dissolution results

On July 23, Jubilant Cadista Pharmaceuticals announced a recall of one lot (#183222) of drospirenone and ethinyl estradiol tablets, USP, 3 mg/ 0.02 mg, 28 x 3 blister pack/carton to the consumer level. The affected product is being recalled because of out-of-specification (OOS) dissolution results at the 3-month stability time point. OOS dissolution may decrease product efficacy.

The recalled product is packaged in a carton with three blister cards, each containing 28-film coated, biconvex tablets, in the following order: 24 active pink, 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 inert white, round, unscored, film-coated tablets debossed with a “PL.”

To date, Jubilant Cadista Pharmaceuticals has not received any reports of adverse events related to this recall.