FDA-Drug2021-10-13Class II
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
Akorn, Inc.
Hazard
Microbial Contamination of Sterile Products: Confirmed sterility failure identified during stability testing at the 12-month time point.
Sold states
Distributed Nationwide in the USA
Affected count
10,210 bottles
Manufactured in
1925 W Field Ct Ste 300, Lake Forest, IL, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0004-2022Don't want to check this manually?
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