Status
Ongoing
Drug Enforcement D-0006-2025
Defective Delivery System: The dip tube is clogged causing the spray not to work.
Classification
Class II
Report Date
October 9, 2024
Termination Date
—
Product Information
- 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.
- Product quantity
- 45,504 bottles
- Reason for recall
- Defective Delivery System: The dip tube is clogged causing the spray not to work.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide in the USA
Location & Firm
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA
- Address
-
750 Corporate Dr, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0006-2025
- Event ID
- 95389
- Recall initiation date
- September 24, 2024
- Center classification date
- October 3, 2024
- Code info
- 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
- More code info
- —