Azelastine Hydrochloride Nasal Solution recall
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
Why was Azelastine Hydrochloride Nasal Solution recalled?
Defective Delivery System: out of specification result for droplet size distribution at the d90 measurement testing during the 6 month time point..
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot # 659365A, Exp 3/31/2018
- 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
- Recalling firm
- Roxane Laboratories, Inc.
- Quantity
- 74,108 bottles
- Distribution
- Nationwide and Puerto Rico.
- Recall date
- February 1, 2017
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)