Exact FDA event identifier

Event 83408

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket: July 09, 2019
Product types: Drug
Classifications: Class I
Statuses: Terminated
Recalling firm wording: Jubilant Cadista Pharmaceuticals, Inc.

Dossier provenance

Source snapshots represented here

openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Device root-cause evidence is not applicable to this event. No grouped product has the official product type device; this is not an unavailable-enrichment finding.

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 1

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

D-1837-2019

Recall number: D-1837-2019
Initiated: July 09, 2019
Classification: Class I
Status: Terminated
Recalling firm: Jubilant Cadista Pharmaceuticals, Inc.
Quantity: 11,412 cartons/34,236 blister cards/28 tablets each card

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0

Failed dissolution specifications

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed dissolution specifications : failed results at the 3-month stability time point.

Code information

Lot #: 183222, Exp 11/2020

Distribution pattern

USA Nationwide