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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 75992

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

Open FDA event record

Event summary

Timeline bucket
December 14, 2016
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Roxane Laboratories, 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

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

Azelastine Hydrochloride Nasal Solution (Nasal Spray), 0.1% (137 mcg per spray), packaged in 30 mL bottles, Rx only, Distributed by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724, NDC 0054-0293-99

D-0448-2017
Recall number
D-0448-2017
Initiated
December 14, 2016
Classification
Class III
Status
Terminated
Recalling firm
Roxane Laboratories, Inc.
Quantity
74,108 bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
out of specification

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Defective Delivery System: out of specification result for droplet size distribution at the d90 measurement testing during the 6 month time point..

Code information

Lot # 659365A, Exp 3/31/2018

Distribution pattern

Nationwide and Puerto Rico.