Class I
Terminated
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
- Recall Initiated
- July 9, 2019
- Posted
- August 7, 2019
- Recall Number
- D-1837-2019
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 11,412 cartons/34,236 blister cards/28 tablets each card
- Firm Location
- Salisbury, MD, United States
Reason for Recall
Failed dissolution specifications : failed results at the 3-month stability time point.
Distribution
USA Nationwide
Lot / Code Info
Lot #: 183222, Exp 11/2020
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