September 2024 FDA Recall Ryaltris by Glenmark Pharmaceuticals Inc., Usa
D-0006-2025 - Defective Delivery System

This Class II drug recall was voluntarily initiated by Glenmark Pharmaceuticals Inc., Usa on September 24, 2024 for the product Ryaltris. The FDA reported the reason for recall as defective delivery system. The product was distributed Nationwide and the recall is currently ongoing.

Recall Number: D-0006-2025

Reason for Recall
Defective Delivery System: The dip tube is clogged causing the spray not to work.
Initiated
09-24-2024
Reported
10-09-2024
Quantity
45,504 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
95389
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Glenmark Pharmaceuticals Inc., USA
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

Lot# 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

Affected Packages Involved in this Recall

59467-700-27 Ryaltris
59467-700-84 Ryaltris