March 20, 2019
Akorn Inc. is recalling 51,456 bottles of gentamicin sulfate ophthalmic solution after impurities were detected during product testing, according to the March 20, 2019, US Food and Drug Administration (FDA) Enforcement Report.
The recall is for gentamicin sulfate ophthalmic solution, 0.3%, 5-mL bottles (NDC 17478-283-10), from lot 7B71A (Exp. 1/20). The recalled bottles were distributed throughout the United States and in Puerto Rico.
Akorn voluntarily initiated the recall February 22, 2019. On March 11, 2019, the FDA designated it Class II, communicating use of the drug may cause temporary or medically reversible adverse health consequences or a remote possibility of serious harm.
Gentamicin sulfate ophthalmic solution is a prescription aminoglycoside antibiotic used to treat blepharitis, conjunctivitis, and other bacterial infections of and around the eyes.