Recalls / Class III
Class IIID-1168-2018
Product
Azelastine HCl Ophthalmic Solution 0.05%, 6 mL in 10 mL HDPE bottle, 1 bottle per box, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-718-10
- Affected lot / code info
- Lot# 6K89A, 6K90A, 6K92A, exp 9/18
Why it was recalled
Failed Impurities/Degradation Specifications:out-of-specification (OOS) results for Azelastine N-oxide
Recalling firm
- Firm
- Akorn, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1925 W Field Ct Ste 300, N/A, Lake Forest, Illinois 60045-4862
Distribution
- Quantity
- 8,574 bottles
- Distribution pattern
- Nationwide USA
Timeline
- Recall initiated
- 2018-08-08
- FDA classified
- 2018-08-29
- Posted by FDA
- 2018-09-05
- Terminated
- 2020-11-03
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1168-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.