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
Reported: August 7, 2019 Initiated: July 9, 2019 #D-1837-2019
Product Description
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
Reason for Recall
Failed dissolution specifications : failed results at the 3-month stability time point.
Details
- Recalling Firm
- Jubilant Cadista Pharmaceuticals, Inc.
- Units Affected
- 11,412 cartons/34,236 blister cards/28 tablets each card
- Distribution
- USA Nationwide
- Location
- Salisbury, MD
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Jubilant Cadista Pharmaceuticals, Inc.. Units affected: 11,412 cartons/34,236 blister cards/28 tablets each card.
Why was this product recalled? ▼
Failed dissolution specifications : failed results at the 3-month stability time point.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 7, 2019. Severity: Critical. Recall number: D-1837-2019.
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