CLASS III Drug recall · Reported 1 Feb 2017 · FDA Enforcement Report
Azelastine Hydrochloride Nasal Solution (Nasal Spray) recalled
Roxane Laboratories is recalling Azelastine Hydrochloride Nasal Solution (Nasal Spray), 1% (137 mcg per spray), distributed nationwide in the US. The recall was initiated on 14 Dec 2016 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0448-2017
- FDA event ID
- 75992
- Recalling firm
- Roxane Laboratories, Columbus, OH
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 14 Dec 2016
- FDA classified
- 26 Jan 2017
- Reported
- 1 Feb 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Nasal Sprays
Timeline
| 14 Dec 2016 | Recall initiated by company | |
| 26 Jan 2017 | Classified by FDA | +43 days |
| 1 Feb 2017 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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..
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
Nationwide and Puerto Rico.
Questions about this recall
Is Azelastine Hydrochloride Nasal Solution (Nasal Spray), 1% (137 mcg per spray) recalled?
Yes. Roxane Laboratories recalled Azelastine Hydrochloride Nasal Solution (Nasal Spray), 1% (137 mcg per spray) on 14 Dec 2016. The recall is Class III and its status is Terminated. Recall number D-0448-2017.
Why was it recalled?
Defective Delivery System: out of specification result for droplet size distribution at the d90 measurement testing during the 6 month time point..
Which lots are affected?
Lot # 659365A, Exp 3/31/2018
Where was it sold?
Nationwide and Puerto Rico.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Roxane Laboratories
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Furosemide Tablets USP, 20 mg recalled by Roxane LaboratoriesFurosemide | Roxane Laboratories | Other | Nationwide |
Other Azelastine hydrochloride nasal recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Azelastine Hydrochloride Nasal Spray, 15%, 105.5 mcg per spray recalled | Akorn | Potency & Assay | Nationwide |