Drug 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.
D-0006-2025
Product summary
- Event
- Event 95389
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 45,504 bottles
- Official record key
drug-enforcement:D-0006-2025
Official wording
Reason: Defective Delivery System: The dip tube is clogged causing the spray not to work.
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
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Unknown
Defective Delivery System: The dip tube is clogged causing the spray not to work.