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 by: Cipla Ltd., Goa, India, M.L.,, NDC 0037-0245-23
Reported: August 15, 2018 Initiated: July 25, 2018 #D-1075-2018
Product Description
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 by: Cipla Ltd., Goa, India, M.L.,, NDC 0037-0245-23
Reason for Recall
Presence of foreign substance: Potential for glass in the neck area of the glass bottles.
Details
- Recalling Firm
- Mylan Pharmaceuticals Inc.
- Units Affected
- 20,780 bottles
- Distribution
- U.S. Nationwide
- Location
- Morgantown, WV
Frequently Asked Questions
What product was recalled? ▼
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 by: Cipla Ltd., Goa, India, M.L.,, NDC 0037-0245-23. Recalled by Mylan Pharmaceuticals Inc.. Units affected: 20,780 bottles.
Why was this product recalled? ▼
Presence of foreign substance: Potential for glass in the neck area of the glass bottles.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 15, 2018. Severity: Moderate. Recall number: D-1075-2018.
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