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
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot # 659365A, Exp 3/31/2018
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Roxane Laboratories, Inc.
- 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..
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full 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
Product Codes/Lot Numbers:
Lot # 659365A, Exp 3/31/2018
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-0448-2017
Related Recalls
Furosemide Tablets USP, 20 mg, 1000 count bottles, Rx only, Roxane Laboratories, Inc., Columbus, Ohio 43216, NDC 0054-4297-31.
Roxane Laboratories
Class I - Dangerous
Failed Tablet/Capsule Specifications: An unusually thick tablet was reported through a complaint.