Reported Aug 7, 2019 · Terminated
Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/0.02 mg, packaged into a carton containing 3 blister cards each…
Jubilant Cadista Pharmaceuticals, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Jubilant Cadista Pharmaceuticals, Inc. · 207 Kiley Dr · Salisbury, MD · 21801-2249
Is this the product you have?
- 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 byCyndea Pharma, S.L., Olvega (Soria), 42110 Spain
- Distributed byJubilant Cadista Pharmaceuticals, Inc., Salisbury, MD, 21801 USA, NDC 59746-763-43
- Lot codes and dates
Lot #: 183222Exp 11/2020
- Amount recalled
- 11,412 cartons/34,236 blister cards/28 tablets each card
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
Failed dissolution specifications : failed results at the 3-month stability time point.
Using this product could cause serious injury, illness or death — stop using it now.
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