Home / Recalls / Akorn, Inc / D-1471-2022

D-1471-2022 Class III Ongoing

Recalled by Akorn, Inc — Gurnee, IL

Recall Details

Product Type
Drugs
Report Date
September 7, 2022
Initiation Date
August 8, 2022
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
5,226 Cartons (60 vials/carton)

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

Reason for Recall

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

Distribution Pattern

Distributed Nationwide in the USA

Code Information

Lot #: 9N72, EXP 09/30/2022

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