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Betaxolol Ophthalmic Solution, USP, 0.5%, (Betaxolol HCl 5.6 mg/mL), 5 mL dropper bottle, Rx only...

FDA Recall #D-0004-2022 — Class II — October 4, 2021

Recall #D-0004-2022 Date: October 4, 2021 Classification: Class II Status: Terminated

Product Description

Betaxolol Ophthalmic Solution, USP, 0.5%, (Betaxolol HCl 5.6 mg/mL), 5 mL dropper bottle, Rx only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. Carton NDC: 17478-705-10, Bottle NDC 17478-705-11

Reason for Recall

Microbial Contamination of Sterile Products: Confirmed sterility failure identified during stability testing at the 12-month time point.

Recalling Firm

Akorn, Inc. — Lake Forest, IL

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

10,210 bottles

Distribution

Distributed Nationwide in the USA

Code Information

Lot 0B61A, Exp 01/31/2022

Status

Terminated

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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