D-1837-2019 Class I Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- August 7, 2019
- Initiation Date
- July 9, 2019
- Termination Date
- May 7, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11,412 cartons/34,236 blister cards/28 tablets each card
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.
Distribution Pattern
USA Nationwide
Code Information
Lot #: 183222, Exp 11/2020