The National Agency for Food and Drugs Administration and Control (NAFDAC) is notifying the public of the recall of forty five (45,000) units of Ryaltris (olopatadine hydrochloride and mometasone furoate) nasal spray, manufactured by Glenmark Pharmaceutical Inc. The company recalled the affected lot due to defective delivery system and which is a safety concern.
Ryaltris is an antihistamine and a corticosteroid nasal spray, used to treat symptoms of seasonal allergies in people 12 years of age and older.
The product may lead to temporary or medically reversible adverse health consequences, though the probability of serious harm is remote.
Product Details
The details of the affected product are as follows;
Product Name | Product Manufacturer | Pack Size | NDC | Batch No | Expiry Date | |
Ryaltris | Glenmark | 240 metered | NDC 59467- 700-27 | 14230425 | 11/25 | |
(Olopatadine | Pharmaceuticals | sprays/bottle |
|
| ||
hydrochloride | Inc., USA, New |
|
|
| ||
14240024 | 12/25 | |||||
and | Jersey |
| ||||
Mometasone |
|
| ||||
14240029 | 12/25 | |||||
furoate) Nasal |
|
| ||||
14240076 | 1/26 | |||||
Spray 665 |
|
| ||||
mcg/25 mcg per |
|
| ||||
14240082 | 1/26 | |||||
spray |
|
| ||||
14240090 | 1/26 | |||||
|
|
| 14240100 | 1/26 |
NAFDAC implores importers, distributors, retailers and consumers to exercise caution and vigilance within the supply chain to avoid the importation, distribution, sale and use of the affected lots of the product. All medical products must be obtained from authorized/licensed suppliers. The products’ authenticity and physical condition should be carefully checked.
Anyone in possession of the affected lots is advised to immediately discontinue sale or use and submit stock to the nearest NAFDAC office. If you have used this product, or someone you know, have used it, or suffered any adverse reaction/event after use, you are advised to seek immediate medical advice from a qualified healthcare professional.
Healthcare professionals and consumers are advised to report any suspicion of substandard and falsified medicines to the nearest NAFDAC office, NAFDAC on 0800- 162-3322 or via email: sf.alert@nafdac.gov.ng
Similarly, healthcare professionals and patients are also encouraged to report adverse events or side effects related to the use of the medicinal product to the nearest NAFDAC office, or through the use of the E-reporting platforms available on the NAFDAC website www.nafdac.gov.ng or via the Med-safety application available for download on android and IOS stores or via e-mail
on pharmacovigilance@nafdac.gov.ng
NAFDAC….. Customer-focused, Agency-minded!!!
