Akorn, Inc. recalls Gentamicin Sulfate Ophthalmic Solution, USP, 0.3%, 5 mL bottle, Rx only, Manufactured for: Akorn, Inc., Lake Forest, IL
Recalled March 20, 2019 · FDA recall D-0993-2019 · Akorn
Hazard
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. · FDA Class II
Units
51,456 bottles
Sold at
Nationwide USA and Puerto Rico
Description
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.
Product
Gentamicin Sulfate Ophthalmic Solution, USP, 0.3%, 5 mL bottle, Rx only, Manufactured for: Akorn, Inc., Lake Forest, IL 60045; NDC 17478-283-10.
Manufacturer(s)
Akorn, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →