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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