Drug product
Azelastine Hydrochloride Nasal Solution (Nasal Spray), 0.1% (137 mcg per spray), packaged in 30 mL bottles, Rx only, Distributed by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724, NDC 0054-0293-99
D-0448-2017
Product summary
- Event
- Event 75992
- Status
- Terminated
- Classification
- Class III
- Quantity
- 74,108 bottles
- Official record key
drug-enforcement:D-0448-2017
Official wording
Reason: Defective Delivery System: out of specification result for droplet size distribution at the d90 measurement testing during the 6 month time point..
Code information: Lot # 659365A, Exp 3/31/2018
Distribution pattern: Nationwide and Puerto Rico.
Derived failure modes
-
Potency or specification failure
out of specification