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FDAFDA · Food and drugs·Recall number D-1837-2019

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

Published August 7, 2019 · Recall initiated: July 9, 2019

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

Failed dissolution specifications : failed results at the 3-month stability time point.

What to do

Voluntary: Firm initiated · E-Mail

Recall details

Manufacturer
Jubilant Cadista Pharmaceuticals, Inc.
Distributor
USA Nationwide
Lot
Lot #: 183222, Exp 11/2020
Risk classification
Class I
Area (FDA)
drug
Country
United States

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