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Timolol Maleate Ophthalmic Solution, USP, 0.5%, 5 x 0.3 mL Single-Dose Vials, Rx Only, Sterile, M...

FDA Recall #D-1471-2022 — Class III — August 8, 2022

Recall #D-1471-2022 Date: August 8, 2022 Classification: Class III Status: Ongoing

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

Identification of an unknown impurity at the 12-month stability point. Further investigation has identified the impurity as Timolol Phenol S-Oxide.

Recalling Firm

Akorn, Inc — Gurnee, IL

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Drugs

Product Quantity

5,226 Cartons (60 vials/carton)

Distribution

Distributed Nationwide in the USA

Code Information

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

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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