Recalls / Class II
Class IID-0424-2019
Product
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.
- 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: GA70535, Exp. April 2019
Why it was recalled
Defective Container: Potential for broken 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, Morgantown, West Virginia 26505-2730
Distribution
- Quantity
- 10,390 bottles
- Distribution pattern
- Nationwide in the USA.
Timeline
- Recall initiated
- 2019-02-01
- FDA classified
- 2019-02-04
- Posted by FDA
- 2019-02-13
- Terminated
- 2019-09-09
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0424-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.