Drug 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
D-1075-2018
Product summary
- Event
- Event 77850
- Status
- Terminated
- Classification
- Class II
- Quantity
- 20,780 bottles
- Official record key
drug-enforcement:D-1075-2018
Official wording
Reason: Presence of foreign substance: Potential for glass in the neck area of the glass bottles.
Code information: Lot #: GA70246, GA70254, Exp 02/2019
Distribution pattern: U.S. Nationwide
Derived failure modes
-
Foreign material or chemical contamination
foreign substance