FDA-Drug2019-08-07Class I
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
Jubilant Cadista Pharmaceuticals, Inc.
Hazard
Failed dissolution specifications : failed results at the 3-month stability time point.
Sold states
USA Nationwide
Affected count
11,412 cartons/34,236 blister cards/28 tablets each card
Manufactured in
207 Kiley Dr, N/A, Salisbury, MD, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1837-2019Don't want to check this manually?
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