D-0448-2017 Class III Terminated
FDA drug recall D-0448-2017 was initiated by Roxane Laboratories, Inc. on December 14, 2016 and is designated Class III. Reason for recall: Defective Delivery System: out of specification result for droplet size distribution at the d90 measurement testing during the 6 month time point.. The recall status is terminated (terminated December 15, 2017). Affected quantity: 74,108 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- February 1, 2017
- Initiation Date
- December 14, 2016
- Termination Date
- December 15, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 74,108 bottles
Product Description
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
Reason for Recall
Defective Delivery System: out of specification result for droplet size distribution at the d90 measurement testing during the 6 month time point..
Distribution Pattern
Nationwide and Puerto Rico.
Code Information
Lot # 659365A, Exp 3/31/2018