Reported Feb 13, 2019 · Terminated

Dymista (azelastine hydrochloride and fluticasone propionate) Nasal Spray, 137 mcg/50 mcg per spray, 120 Metered…

Mylan Pharmaceuticals Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Mylan Pharmaceuticals Inc. · 781 Chestnut Ridge Rd · Morgantown, WV · 26505-2730

Is this the product you have?

  • 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 byCipla Ltd., Goa, India, M.L. No. 546
  • ForMeda Pharmaceuticals Inc., Somerset, New Jersey 08873-4120, NDC 0037-0245-23
Lot codes and dates
  • Lot
    • GA70535
    • Exp. April 2019
Amount recalled
10,390 bottles

Where it was sold

  • Nationwide

Why it was recalled

Defective Container: Potential for broken glass in the neck area of the glass bottles.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Sep 9, 2019 · Data as of Sep 19, 5:55 PM UTC

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