Drug recall: Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/0.02 mg, packaged into a carton containing 3 blister cards each…
Class I FDA enforcement event 83408. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Failed dissolution specifications : failed results at the 3-month stability time point.
Class I, in the words of FDA
a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death
Jubilant Cadista Pharmaceuticals, Inc. started this drug recall on 9 Jul 2019. The firm address in the FDA record is in Salisbury, MD. FDA put the recall in Class I. FDA event 83408 has 1 product record. The first FDA enforcement report date is 7 Aug 2019. The record gives the status Terminated, with the termination date 7 May 2021.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
USA Nationwide
Recalling firm
Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
1 product record in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-1837-2019 | 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,… | 11,412 cartons/34,236 blister cards/28 tablets each card | Class I | Terminated | 7 Aug 2019 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class I: The highest of the three FDA recall classes.
The event in context
- Drug events that started in 2019
- 362
- Share of these events in Class I
- 10%
- Product records in this event
- 1Median of the firm: 1
- Events of the firm on the register
- 25
Other events of the firm
Official channels
- FDA enforcement report D-1837-2019The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 83408. https://recallregister.com/fda/i/83408/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA drug enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
USA Nationwide
- What quantity of product is in FDA event 83408?
- The FDA record gives this quantity:
11,412 cartons/34,236 blister cards/28 tablets each card
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many drug recalls of 2019 have the same class?
- 10% of the 362 drug events that started in 2019 are in Class I.