D-0006-2025 Class II Ongoing
FDA drug recall D-0006-2025 was initiated by Glenmark Pharmaceuticals Inc., USA on Sep 24, 2024 and is designated Class II. Reason for recall: Defective Delivery System: The dip tube is clogged causing the spray not to work. The recall status is ongoing. Affected quantity: 45,504 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Oct 9, 2024
- Initiation Date
- Sep 24, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 45,504 bottles
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.
Distribution Pattern
Nationwide in the USA
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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0006-2025
- openFDA file date
- Oct 6, 2026
- Loaded by RegDataLab
- Oct 12, 2026