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

Recall Number: D-1168-2018

Firm: Akorn, Inc.

Classification: Class III

Status: Terminated

Report Date: 20180905

Initiation Date: 20180808

Termination Date: 20201103

Failed Impurities/Degradation Specifications:out-of-specification (OOS) results for Azelastine N-oxide

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