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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 95389

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

Open FDA event record

Event summary

Timeline bucket
September 24, 2024
Product types
Drug
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Glenmark Pharmaceuticals Inc., USA

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

Ryaltris (olopatadine hydrochloride and mometasone fluorate) Nasal Spray, 665 mcg/25 mcg per spray, 240 Metered Sprays/bottle, 29 g net fill weight, Distr. by Hikma Specialty USA Inc., Columbus, OH 43328, hikma, Glenmark Specialty SA. NDC 59467-700-27.

D-0006-2025
Recall number
D-0006-2025
Initiated
September 24, 2024
Classification
Class II
Status
Ongoing
Quantity
45,504 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Defective Delivery System: The dip tube is clogged causing the spray not to work.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Defective Delivery System: The dip tube is clogged causing the spray not to work.

Code information

Lots 14230425, Exp Date, Nov-25; 14240024, Exp Date Dec-25; 14240029, Exp Date Dec-25; 14240076, Exp Date Jan-26; 14240082 Exp Date, Jan-26, 14240090, Exp Date Jan-26; and 14240100, Exp Date Jan-26

Distribution pattern

Nationwide in the USA