Akorn, Inc. recalls Betaxolol Ophthalmic Solution, USP, 0.5%, (Betaxolol HCl 5.6 mg/mL), 5 mL dropper bottle, Rx only, Sterile, Manufactured
Recalled October 13, 2021 · FDA recall D-0004-2022 · Akorn
Hazard
Microbial Contamination of Sterile Products: Confirmed sterility failure identified during stability testing at the 12-month time point. · FDA Class II
Units
10,210 bottles
Sold at
Distributed Nationwide in the USA
Description
Microbial Contamination of Sterile Products: Confirmed sterility failure identified during stability testing at the 12-month time point.
Product
Betaxolol Ophthalmic Solution, USP, 0.5%, (Betaxolol HCl 5.6 mg/mL), 5 mL dropper bottle, Rx only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. Carton NDC: 17478-705-10, Bottle NDC 17478-705-11
Manufacturer(s)
Akorn, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →