FDA withdraws unapproved ophthalmic balanced salt solutions

The FDA has ordered manufacturers of unapproved ophthalmic balanced salt solutions (BSS) to discontinue production. The unapproved BSS products were found to contain contaminants and defects that have led to permanent vision loss. Companies must stop making these products within 60 days and stop shipping these products within 120 days or face regulatory action. This warning does not include approved ophthalmic BSS products such as Alcon’s BSS and BSS-plus or Akorn’s Balanced Salt Solution and Endosol Extra.

Ophthalmic BSS are sterile, isotonic, irrigating solutions used during surgical procedures of the eye.

For more information visit www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/SelectedEnforcementActionsonUnapprovedDrugs/ucm119630.htm.