Timolol Maleate Ophthalmic Solution, USP, 0.5%, 5 x 0.3 mL Single-Dose Vials, Rx Only, Sterile, Manufactured for: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-189-24
Recall Number: D-1471-2022
Firm: Akorn, Inc
Classification: Class III
Status: Ongoing
Report Date: 20220907
Initiation Date: 20220808
Termination Date:
Reason for Recall
Failed Impurities/Degradation Specifications: Identification of an unknown impurity at the 12-month stability point.
Product Description
Timolol Maleate Ophthalmic Solution, USP, 0.5%, 5 x 0.3 mL Single-Dose Vials, Rx Only, Sterile, Manufactured for: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-189-24