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..
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
Lot numbers, UPCs & expiration codes
Lot # 659365A, Exp 3/31/2018
Where it was sold
Nationwide and Puerto Rico.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0448-2017
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Dec 14, 2016
- FDA report date
- Feb 1, 2017
- Quantity
- 74,108 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Roxane Laboratories, Inc.
Original FDA data
Every field from FDA enforcement report D-0448-2017, exactly as published.
Show all FDA fields
- City
- Columbus
- State
- OH
- Status
- Terminated
- Country
- United States
- Event ID
- 75992
- Address
- 1809 Wilson Rd
- Code information
- Lot # 659365A, Exp 3/31/2018
- Postal code
- 43228-9579
- Report date
- Feb 1, 2017
- Product type
- Drugs
- Recall number
- D-0448-2017
- Classification
- Class III
- Recalling firm
- Roxane Laboratories, Inc.
- Product quantity
- 74,108 bottles
- Termination date
- Dec 15, 2017
- 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..
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide and Puerto Rico.
- Recall initiation date
- Dec 14, 2016
- Initial firm notification
- Letter
- Center classification date
- Jan 26, 2017