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
Reason for recall: Failed Impurities/Degradation Specifications:out-of-specification (OOS) results for Azelastine N-oxide
Recall initiated: 20180808
Status: Terminated
Classification: Class III
Recall type: Voluntary: Firm initiated