FDA Drug recall D-0448-2017
Azelastine Hydrochloride Nasal Solution (Nasal Spray), 0.1% (137 mcg per spray), packaged in 30 mL bottles, Rx only, Distributed by: West-W…
- FDA Drug
- Class III
- terminated
- Published 2017-02-01
On 2017-02-01 the FDA classified a Class III recall of Azelastine Hydrochloride Nasal Solution (Nasal Spray), 0.1% (137 mcg per spray), packaged in 30 mL bottles, Rx only, Distributed by: West-W… by Roxane Laboratories, citing defective Delivery System: out of specification result for droplet size distribution at the d90 measurement testing during the 6 month time point.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0448-2017 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2016-12-14 |
| Published | 2017-02-01 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Roxane Laboratories |
| Distribution | US |
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
Reason
Defective Delivery System: out of specification result for droplet size distribution at the d90 measurement testing during the 6 month time point..
Identifiers
| code_info | Lot # 659365A, Exp 3/31/2018 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0448-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.