Mylan Pharmaceuticals Inc. recalls Dymista (azelastine hydrochloride and fluticasone propionate) Nasal Spray, 137 mcg/50 mcg per spray, 120 Metered Sprays…
- Recall date
- February 1, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0424-2019
- FDA classification
- Class II
- Brand / firm
- Mylan Pharmaceuticals Inc.
- Sold / distributed
- Nationwide in the USA.
Why it was recalled
Defective Container: Potential for broken glass in the neck area of the glass bottles.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Dymista (azelastine hydrochloride and fluticasone propionate) Nasal Spray, 137 mcg/50 mcg per spray, 120 Metered Sprays, 23 g net fill weight bottle, Rx Only, Manufactured by: Cipla Ltd., Goa, India, M.L. No. 546; For: Meda Pharmaceuticals Inc., Somerset, New Jersey 08873-4120, NDC 0037-0245-23.
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