Drug recall
Azelastine Hydrochloride Nasal Solution (Nasal Spray), 0.1% (137 mcg per spray), packaged in 30 mL bottles, Rx…
FDA recall event 75992 · Class III · Roxane Laboratories, Inc.
Key facts
| Event ID | 75992 |
|---|---|
| Recall numbers | D-0448-2017 |
| Recalling firm | Roxane Laboratories, Inc. |
| Product type | Drugs |
| Products | 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… |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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.. |
| Initiation date | Dec 14, 2016 |
| Report date | Feb 1, 2017 |
| Termination date | Dec 15, 2017 |
| City | Columbus |
| State | OH |
| Country | United States |
| FEI number | 1510690 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: