Azelastine Hydrochloride Nasal Solution — Class III drug recall D-0448-2017
Terminated recall by Roxane Laboratories, Inc., reported 2017-02-01, distributed nationwide. Defective Delivery System: out of specification result for droplet size distribution at the d90 measurement te
| Recall number | D-0448-2017 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Roxane Laboratories, Inc., Columbus, OH, United States |
| Recall initiated | 2016-12-14 |
| Classified | 2017-01-26 |
| Reported by FDA | 2017-02-01 |
| Terminated | 2017-12-15 |
| Distributed | Nationwide (US) |
| Quantity | 74,108 bottles |
| Reason classes | specification failure |
| NDC | 00054-0293-99 |
| Lot numbers | 659365A |
| Expiration dates | 2018-03-31 |
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 for recall
Defective Delivery System: out of specification result for droplet size distribution at the d90 measurement testing during the 6 month time point..
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0448-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.