Recall
FDAHealthSeptember 24, 2024

Glenmark Pharmaceuticals Inc., USA — 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 Hikm

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

Is this relevant to me?

Geography
Nationwide
Source agency
FDA
Category
Health
Published
September 24, 2024

Nationwide in the USA

What's affected?

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.
UPC
0359467700276
Lot code
14230425

Additional details

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

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 45,504 bottles.

View original FDA notice →

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