Drug 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
D-1837-2019
Product summary
- Event
- Event 83408
- Status
- Terminated
- Classification
- Class I
- Quantity
- 11,412 cartons/34,236 blister cards/28 tablets each card
- Official record key
drug-enforcement:D-1837-2019
Official wording
Reason: Failed dissolution specifications : failed results at the 3-month stability time point.
Code information: Lot #: 183222, Exp 11/2020
Distribution pattern: USA Nationwide
Derived failure modes
-
Potency or specification failure
Failed dissolution specifications