Akorn, Inc. recalls Ketorolac Tromethamine Ophthalmic Solution, 0.5%, Packaged as a) 10 mL dropper bottle, NDC 17478-209-11; (b) 3 mL droppe
Recalled January 25, 2023 · FDA recall D-0141-2023 · Akorn
Hazard
CGMP Deviations: · FDA Class II
Units
314,543 10ml,3ml, 5ml bottles
Sold at
Nationwide in the USA
Description
CGMP Deviations:
Product
Ketorolac Tromethamine Ophthalmic Solution, 0.5%, Packaged as a) 10 mL dropper bottle, NDC 17478-209-11; (b) 3 mL dropper bottle, NDC 17478-209-19; (c) 5 mL dropper bottle, NDC 17478-209-10; Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045.
Manufacturer(s)
Akorn, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →