Akorn, Inc. recalls Sulfacetamide Sodium Ophthalmic Solution, USP, 10%, Sterile, Rx Only, 15 mL bottles, Mfd. by: Akorn, Inc., Lake Forest,
Recalled June 8, 2016 · FDA recall D-0949-2016 · Akorn
Hazard
Lack of Assurance of Sterility; some lots failed Antimicrobial Effectiveness Testing on stability · FDA Class II
Units
57,920 bottles
Sold at
Nationwide and Puerto Rico.
Description
Lack of Assurance of Sterility; some lots failed Antimicrobial Effectiveness Testing on stability
Product
Sulfacetamide Sodium Ophthalmic Solution, USP, 10%, Sterile, Rx Only, 15 mL bottles, Mfd. by: Akorn, Inc., Lake Forest, IL 60045 --- NDC 17478-221-12
Manufacturer(s)
Akorn, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →