Ketorolac Tromethamine Ophthalmic Solution, 0.5%, Sterile, packaged in a) 3mL bottles, b bottles) 5 mL, and c)10 mL bottles, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs

Recall Number: D-0813-2023

Firm: Akorn, Inc.

Classification: Class II

Status: Ongoing

Report Date: 20230607

Initiation Date: 20230426

Termination Date:

Reason for Recall

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Product Description

Ketorolac Tromethamine Ophthalmic Solution, 0.5%, Sterile, packaged in a) 3mL bottles, b bottles) 5 mL, and c)10 mL bottles, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs