FDA recall D-0006-2025

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.

Reason for recall

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

Distribution

Nationwide in the USA

Key facts

Status

Ongoing

Initiation date

2024-09-24

Report date

2024-10-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

Mahwah, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0006-2025