Jubilant Cadista Pharmaceuticals, Inc. recalls Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/0.02 mg, packaged into a carton containing 3 blister cards each b…
- Recall date
- July 9, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-1837-2019
- FDA classification
- Class I
- Brand / firm
- Jubilant Cadista Pharmaceuticals, Inc.
- Sold / distributed
- USA Nationwide
Why it was recalled
Failed dissolution specifications : failed results at the 3-month stability time point.
Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.
What was recalled
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
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