Akorn, Inc. recalls Atropine Sulfate Ophthalmic 1% Solution, USP, 5mL per bottle, Sterile, Rx Only, Manufactured by: Akorn, Inc., Lake Fore…

Recall date

February 21, 2018

Source

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

Recall number

D-0577-2018

FDA classification

Class III

Brand / firm

Akorn, Inc.

Sold / distributed

Nationwide in the USA

Why it was recalled

Failed Stability Specification: OOS low viscosity results discovered during retain testing.

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

What was recalled

Atropine Sulfate Ophthalmic 1% Solution, USP, 5mL per bottle, Sterile, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-215-05