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FDAFDA · Food and drugs·Recall number D-1471-2022

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

Published September 7, 2022 · Recall initiated: August 8, 2022

Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
Akorn, Inc
Distributor
Distributed Nationwide in the USA
Lot
Lot #: 9N72, EXP 09/30/2022
Risk classification
Class III
Area (FDA)
drug
Country
United States

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