Akorn, Inc recalls Timolol Maleate Ophthalmic Solution, USP, 0.5%, 5 x 0.3 mL Single-Dose Vials, Rx Only, Sterile, Manufactured for: Akorn

Recalled September 7, 2022 · FDA recall D-1471-2022 · Akorn

Hazard

Failed Impurities/Degradation Specifications: Identification of an unknown impurity at the 12-month stability point. · FDA Class III

Units

5,226 Cartons (60 vials/carton)

Sold at

Distributed Nationwide in the USA

Description

Failed Impurities/Degradation Specifications: Identification of an unknown impurity at the 12-month stability point.

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

Manufacturer(s)

Akorn, Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →