Exact FDA event identifier

Event 81980

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

Open FDA event record

Event summary

Timeline bucket: February 01, 2019
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Mylan 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

Dymista (azelastine hydrochloride and fluticasone propionate) Nasal Spray, 137 mcg/50 mcg per spray, 120 Metered Sprays, 23 g net fill weight bottle, Rx Only, Manufactured by: Cipla Ltd., Goa, India, M.L. No. 546; For: Meda Pharmaceuticals Inc., Somerset, New Jersey 08873-4120, NDC 0037-0245-23.

D-0424-2019

Recall number: D-0424-2019
Initiated: February 01, 2019
Classification: Class II
Status: Terminated
Recalling firm: Mylan Pharmaceuticals Inc.
Quantity: 10,390 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Defective Container: Potential for broken glass in the neck area of the glass bottles.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Defective Container: Potential for broken glass in the neck area of the glass bottles.

Code information

Lot: GA70535, Exp. April 2019

Distribution pattern

Nationwide in the USA.