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.
Reported: February 13, 2019 Initiated: February 1, 2019 #D-0424-2019
Product Description
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.
Reason for Recall
Defective Container: Potential for broken glass in the neck area of the glass bottles.
Details
- Recalling Firm
- Mylan Pharmaceuticals Inc.
- Units Affected
- 10,390 bottles
- Distribution
- Nationwide in the USA.
- Location
- Morgantown, WV
Frequently Asked Questions
What product 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.. Recalled by Mylan Pharmaceuticals Inc.. Units affected: 10,390 bottles.
Why was this product recalled? ▼
Defective Container: Potential for broken glass in the neck area of the glass bottles.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 13, 2019. Severity: Moderate. Recall number: D-0424-2019.
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