Class III Recall

Akorn, Inc

Product
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
Reason
Failed Impurities/Degradation Specifications: Identification of an unknown impurity at the 12-month stability point.
Classification
Class III
Status
Ongoing
Lot
Lot #: 9N72, EXP 09/30/2022
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.