Mylan Recalls Dymista Nasal Spray Due to Potential Glass Contamination
Mylan Pharmaceuticals is recalling 20,780 bottles of Dymista nasal spray because glass fragments may be present in the neck area of the bottles.
The agency’s classification
FDA (Drugs): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (glass contamination) where injury has not yet been reported, fitting the 'High' severity criteria for potential physical injury without confirmed cases.
Plain-English summary
Mylan Pharmaceuticals Inc. is recalling 20,780 bottles of Dymista (azelastine hydrochloride and fluticasone propionate) Nasal Spray. The product is a prescription nasal spray packaged in 23 g glass bottles. The recall involves specific lots with expiration dates of 02/2019.
The recall was initiated due to the potential presence of glass in the neck area of the glass bottles. This defect poses a risk of injury if the glass fragments are inhaled or ingested. The affected product was distributed nationwide in the United States.
Consumers who have this product should stop using it immediately. They should contact their healthcare provider or pharmacist for guidance on disposal or replacement. The specific lot numbers involved are GA70246 and GA70254.
The recalled product
- Product
- DYMISTA (AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE)
- Brand
- DYMISTA
- Manufacturer
- Mylan Pharmaceuticals Inc.
- Category
- Drug — Nasal Spray
- Affected units
- 20,780
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot #: GA70246
- GA70254
- Exp 02/2019
Distribution
Distributed nationwide across the United States.
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