Severity
Low
LowClass IIITerminated
FDA Drug recall · Reported February 1, 2017
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
Defective Delivery System: out of specification result for droplet size distribution at the d90 measurement testing during the 6 month time point..
Roxane Laboratories, Inc. recalled Azelastine Hydrochloride Nasal Solution (Nasal Spray), 0.1% (137 mcg per spray), packaged… - a low-severity action.
Azelastine Hydrochloride Nasal Solution (Nasal Spray), 0.1% (137 mcg per spray), packaged… was recalled by Roxane Laboratories, Inc. in February 1, 2017. Reason: Defective Delivery System: out of specification result for droplet size distribution at the d90 measurement t…. Check the official notice for the remedy. Verify recall #D-0448-2017 with the FDA Drug before acting.
The recall
Roxane Laboratories, Inc. issued this low-severity FDA Drug recall-Defective Delivery System: out of specification result for droplet size distribution at the d90 measurement t….
- Low
- severity level
- Class III
- classification
- February 1, 2017
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0448-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0448-2017) was formally reported on February 1, 2017, with the manufacturer initiating the action on December 14, 2016. It is classified under Low severity (Class III), with a current status of Terminated. Roxane Laboratories, Inc. is listed as the recalling firm, operating out of Columbus, OH. Federal records list the affected scope as 74,108 bottles.
The documented reason for this recall is: Defective Delivery System: out of specification result for droplet size distribution at the d90 measurement testing during the 6 month time point.. Distribution data in the federal record shows the product reached: Nationwide and Puerto Rico.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 5 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Drugs & Medications recalls over time
Where this recall sits in its category - 14,287 drugs & medications recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
74,108 bottles
Related Recalls
6
5 from same agency
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..
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | D-0448-2017 |
| Date reported | February 1, 2017 |
| Date initiated | December 14, 2016 |
| Recalling firm | Roxane Laboratories, Inc. |
| Firm location | Columbus, OH |
| Affected scope | 74,108 bottles |
| Distribution | Nationwide and Puerto Rico. |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-0448-2017) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Roxane Laboratories, Inc.. Units affected: 74,108 bottles.
Why was this product recalled? ▼
Defective Delivery System: out of specification result for droplet size distribution at the d90 measurement testing during the 6 month time point..
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 1, 2017. Severity: Low. Recall number: D-0448-2017.
Where was the recalled product distributed? ▼
Distribution: Nationwide and Puerto Rico..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0448-2017) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported February 1, 2017. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.