Akorn, Inc. recalls Gentamicin Sulfate Ophthalmic Solution, USP, 0.3%, 5 mL bottle, Rx only, Manufactured for: Akorn, Inc., Lake Forest, IL…

Recall date

February 22, 2019

Source

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

Recall number

D-0993-2019

FDA classification

Class II

Brand / firm

Akorn, Inc.

Sold / distributed

Nationwide USA and Puerto Rico

Why it was recalled

Failed Impurities/Degradation Specifications: High Out-of-Specification (OOS) results for Individual and Total Impurities that have been identified at the 18 months stability testing time point.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Gentamicin Sulfate Ophthalmic Solution, USP, 0.3%, 5 mL bottle, Rx only, Manufactured for: Akorn, Inc., Lake Forest, IL 60045; NDC 17478-283-10.