PlainRecalls
FDA Drug Moderate Class II Ongoing

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.

Reported: October 9, 2024 Initiated: September 24, 2024 #D-0006-2025

Product Description

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.

Reason for Recall

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

Details

Units Affected
45,504 bottles
Distribution
Nationwide in the USA
Location
Mahwah, NJ

Frequently Asked Questions

What product was recalled?
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.. Recalled by Glenmark Pharmaceuticals Inc., USA. Units affected: 45,504 bottles.
Why was this product recalled?
Defective Delivery System: The dip tube is clogged causing the spray not to work.
Which agency issued this recall?
This recall was issued by the FDA Drug on October 9, 2024. Severity: Moderate. Recall number: D-0006-2025.