Akorn, Inc. recalls Gentamicin Sulfate Ophthalmic Solution, USP 0.3%, 5 mL dropper bottle, Rx Only, Manufactured by: Akorn, Inc. Lake Forest
Recalled February 6, 2019 · FDA recall D-0414-2019 · Akorn
Hazard
Presence of Particulate Matter: Crystalline particles were noticed at the 24 month clarity testing. · FDA Class II
Units
149,159 5mL bottles
Sold at
Nationwide USA and Puerto Rico
Description
Presence of Particulate Matter: Crystalline particles were noticed at the 24 month clarity testing.
Product
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
Manufacturer(s)
Akorn, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →