Reported Feb 1, 2017 · Terminated
Azelastine Hydrochloride Nasal Solution (Nasal Spray), 0.1% (137 mcg per spray), packaged in 30 mL bottles, Rx only,…
Roxane Laboratories, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Roxane Laboratories, Inc. · 1809 Wilson Rd · Columbus, OH · 43228-9579
Is this the product you have?
- Azelastine Hydrochloride Nasal Solution (Nasal Spray), 0.1% (137 mcg per spray), packaged in 30 mL bottles, Rx only
- Distributed byWest-Ward Pharmaceuticals Corp., Eatontown, NJ 07724, NDC 0054-0293-99
- Lot codes and dates
Lot # 659365AExp 3/31/2018
- Amount recalled
- 74,108 bottles
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
- PR
Why it was recalled
Defective Delivery System: out of specification result for droplet size distribution at the d90 measurement testing during the 6 month time point..
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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