Akorn, Inc. recalls Atropine Sulfate Ophthalmic Solution, USP 1%, For Topical Application To The Eye, 2 mL bottle, Sterile, Rx only, Distri…

Recall date

January 30, 2023

Source

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

Recall number

D-0265-2023

FDA classification

Class III

Brand / firm

Akorn, Inc.

Sold / distributed

Nationwide in the USA and Puerto Rico

Why it was recalled

Failed Stability Specifications: Out of specification test results for viscosity was identified at the 12M stability timepoint.

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

What was recalled

Atropine Sulfate Ophthalmic Solution, USP 1%, For Topical Application To The Eye, 2 mL bottle, Sterile, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. NDC: 17478-215-02