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

Recall Number: D-0414-2019

Firm: Akorn, Inc.

Classification: Class II

Status: Terminated

Report Date: 20190206

Initiation Date: 20181008

Termination Date: 20220615

Reason for Recall

Presence of Particulate Matter: Crystalline particles were noticed at the 24 month clarity testing.

Product Description

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