Drospirenone and Ethinyl Estradiol Tablets recall: Failed Dissolution
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
Why was Drospirenone and Ethinyl Estradiol Tablets recalled?
Failed dissolution specifications : failed results at the 3-month stability time point.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: 183222, Exp 11/2020
- Product
- 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
- Recalling firm
- Jubilant Cadista Pharmaceuticals, Inc.
- Quantity
- 11,412 cartons/34,236 blister cards/28 tablets each card
- Distribution
- USA Nationwide
- Recall date
- August 7, 2019
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (drug)