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

FDA recall notice · announced February 1, 2017 · Roxane Laboratories

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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

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..

Notes

Distribution: Nationwide and Puerto Rico.
Lot/code information: Lot # 659365A, Exp 3/31/2018
Quantity: 74,108 bottles
Status: Terminated
Products in this recall event:
- 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 (D-0448-2017)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.