Recalls / Class I
Class ID-1837-2019
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences 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
- Affected lot / code info
- Lot #: 183222, Exp 11/2020
Why it was recalled
Failed dissolution specifications : failed results at the 3-month stability time point.
Recalling firm
- Firm
- Jubilant Cadista Pharmaceuticals, Inc.
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 207 Kiley Dr, N/A, Salisbury, Maryland 21801-2249
Distribution
- Quantity
- 11,412 cartons/34,236 blister cards/28 tablets each card
- Distribution pattern
- USA Nationwide
Timeline
- Recall initiated
- 2019-07-09
- FDA classified
- 2019-08-19
- Posted by FDA
- 2019-08-07
- Terminated
- 2021-05-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1837-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.