FDA-Drug2019-03-20Class II
Gentamicin Sulfate Ophthalmic Solution, USP, 0.3%, 5 mL bottle, Rx only, Manufactured for: Akorn, Inc., Lake Forest, IL 60045; NDC 17478-283-10.
Akorn, Inc.
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.
Sold states
Nationwide USA and Puerto Rico
Affected count
51,456 bottles
Manufactured in
1925 W Field Ct Ste 300, N/A, Lake Forest, IL, United States
Products
Gentamicin Sulfate Ophthalmic Solution, USP, 0.3%, 5 mL bottle, Rx only, Manufactured for: Akorn, Inc., Lake Forest, IL 60045; NDC 17478-283-10.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0993-2019Don't want to check this manually?
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