Drug 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.
D-0424-2019
Product summary
- Event
- Event 81980
- Status
- Terminated
- Classification
- Class II
- Quantity
- 10,390 bottles
- Official record key
drug-enforcement:D-0424-2019
Official wording
Reason: Defective Container: Potential for broken glass in the neck area of the glass bottles.
Code information: Lot: GA70535, Exp. April 2019
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Unknown
Defective Container: Potential for broken glass in the neck area of the glass bottles.