Recalls / Class III
Class IIID-0448-2017
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
- Affected lot / code info
- Lot # 659365A, Exp 3/31/2018
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..
Recalling firm
- Firm
- Roxane Laboratories, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1809 Wilson Rd, N/A, Columbus, Ohio 43228-9579
Distribution
- Quantity
- 74,108 bottles
- Distribution pattern
- Nationwide and Puerto Rico.
Timeline
- Recall initiated
- 2016-12-14
- FDA classified
- 2017-01-26
- Posted by FDA
- 2017-02-01
- Terminated
- 2017-12-15
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0448-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.