Reported Aug 15, 2018 · Terminated

Dymista (azelastine hydrochloride and fluticasone propionate) Nasal Spray, 137 mcg / 50 mcg per spray, packaged in a 23…

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, packaged in a 23 g net fill weight, Rx only
  • Manufactured byCipla Ltd., Goa, India, M.L.,, NDC 0037-0245-23
Lot codes and dates
    • Lot #: GA70246
    • GA70254
    • Exp 02/2019
Amount recalled
20,780 bottles

Where it was sold

  • Nationwide

Why it was recalled

Presence of foreign substance: Potential for 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 Aug 15, 2019 · Data as of Sep 19, 6:23 PM UTC

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