Recalls / Class II
Class IID-1075-2018
Product
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
- Brand name
- Dymista
- Generic name
- Azelastine Hydrochloride And Fluticasone Propionate
- Active ingredients
- Azelastine Hydrochloride, Fluticasone Propionate
- Route
- Nasal
- NDC
- 0037-0245
- FDA application
- NDA202236
- Affected lot / code info
- Lot #: GA70246, GA70254, Exp 02/2019
Why it was recalled
Presence of foreign substance: Potential for glass in the neck area of the glass bottles.
Recalling firm
- Firm
- Mylan Pharmaceuticals Inc.
- Manufacturer
- Viatris Specialty LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 781 Chestnut Ridge Rd, N/A, Morgantown, West Virginia 26505-2730
Distribution
- Quantity
- 20,780 bottles
- Distribution pattern
- U.S. Nationwide
Timeline
- Recall initiated
- 2018-07-25
- FDA classified
- 2018-08-09
- Posted by FDA
- 2018-08-15
- Terminated
- 2019-08-15
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1075-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.