FDA Recall D-1837-2019
Jubilant Cadista Pharmaceuticals, Inc. · Salisbury, MD
Class I — life-threatening Terminated 668 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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
Reason for recall
Failed dissolution specifications : failed results at the 3-month stability time point.
Recall record
- Recall number
D-1837-2019- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Distribution
- USA Nationwide
- Recall initiated
- 2019-07-09
- Classified by FDA Center
- 2019-08-19
- FDA published
- 2019-08-07
- Terminated
- 2021-05-07
- Recalling firm
- Jubilant Cadista Pharmaceuticals, Inc.
- Firm location
- Salisbury, MD