Akorn, Inc. recalls Azelastine HCl Ophthalmic Solution 0.05%, 6 mL in 10 mL HDPE bottle, 1 bottle per box, Rx only, Manufactured by: Akorn,…

Recall date

August 8, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-1168-2018

FDA classification

Class III

Brand / firm

Akorn, Inc.

Sold / distributed

Nationwide USA

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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