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Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5%, 15 mL per dropper bottle, Rx only, Dist...

FDA Recall #D-0153-2023 — Class II — October 13, 2022

Recall #D-0153-2023 Date: October 13, 2022 Classification: Class II Status: Ongoing

Product Description

Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5%, 15 mL per dropper bottle, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031 NDC: 17478-263-12

Reason for Recall

CGMP Deviations:

Recalling Firm

Akorn, Inc. — Gurnee, IL

Classification

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

Product Type

Drugs

Product Quantity

267,678 bottles

Distribution

Nationwide in the USA

Code Information

Lot: 0L42A, 0L50A, EXP 10/31/2022; 1C64A, 1C76A, EXP 2/28/2023; 1G53A, EXP 6/30/2023; 1J26A, 1J25A, 1J48A, 1J54A, EXP 8/31/2023

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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