FDAFDA · Food and drugs·Recall number D-0424-2019
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.
Published February 13, 2019 · Recall initiated: February 1, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Defective Container: Potential for broken glass in the neck area of the glass bottles.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- DYMISTA
- Manufacturer
- Mylan Pharmaceuticals Inc.
- Distributor
- Nationwide in the USA.
- Lot
- Lot: GA70535, Exp. April 2019
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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