Jubilant Cadista Pharmaceuticals, Inc. recalls Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/0.02 mg, packaged into a carton containing 3 blister cards each bl
Recalled August 7, 2019 · FDA recall D-1837-2019 · Jubilant Cadista Pharmaceuticals
Hazard
Failed dissolution specifications : failed results at the 3-month stability time point. · FDA Class I
Units
11,412 cartons/34,236 blister cards/28 tablets each card
Sold at
USA Nationwide
Description
Failed dissolution specifications : failed results at the 3-month stability time point.
Product
Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/0.02 mg, packaged into a carton containing 3 blister cards each blister card contains 28-film coated, biconvex tablets, Rx Only, Manufactured by: Cyndea Pharma, S.L., Olvega (Soria), 42110 Spain, Distributed by: Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD, 21801 USA, NDC 59746-763-43
Manufacturer(s)
Jubilant Cadista Pharmaceuticals, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →