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Recall Observatory FDA recall evidence

Drug product

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

September 24, 2024

Class II

Product summary

Firm
Glenmark Pharmaceuticals Inc., USA
Event
Event 95389
Status
Ongoing
Classification
Class II
Quantity
45,504 bottles
Official record key
drug-enforcement:D-0006-2025

Official wording

Reason: 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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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