Akorn, Inc. recalls Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC 1747…

Recall date

February 21, 2020

Source

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

Recall number

D-0859-2020

FDA classification

Class III

Brand / firm

Akorn, Inc.

Sold / distributed

Nationwide within United States and Puerto Rico

Why it was recalled

Presence of Particulate Matter: Brown spots observed on the inside of the tube of product, identified as tin with trace copper, which are the base of the materials of construction for the tube.

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

What was recalled

Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-622-35