Mylan Recalls Dymista Nasal Spray Due to Broken Glass Risk
Mylan Pharmaceuticals is recalling 10,390 bottles of Dymista nasal spray because the glass bottles may have broken glass in the neck area.
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 (broken glass) 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 10,390 bottles of Dymista (azelastine hydrochloride and fluticasone propionate) Nasal Spray. The product is a prescription nasal spray manufactured by Cipla Ltd. in India for Meda Pharmaceuticals Inc. The specific lot affected is GA70535, which has an expiration date of April 2019.
The recall was initiated due to a defective container issue. The glass bottles have a potential for broken glass in the neck area. This defect poses a risk of injury to consumers who use the product.
The affected product was distributed nationwide in the USA. Consumers who have this specific lot of Dymista should stop using it and contact their healthcare provider or pharmacist for instructions on how to dispose of the product or obtain a replacement.
The recalled product
- Product
- DYMISTA (AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE)
- Brand
- DYMISTA
- Manufacturer
- Mylan Pharmaceuticals Inc.
- Category
- Drug — Nasal Spray
- Hazard
- Affected units
- 10,390
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 (2)
- Lot: GA70535
- Exp. April 2019
Distribution
Distributed nationwide across the United States.
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