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TheraTears Extra (sodium carboxymethylcellulose) 0.25% Lubricant Eye Drops, 30 Sterile Single-Use...

FDA Recall #D-0717-2022 — Class II — September 8, 2021

Recall #D-0717-2022 Date: September 8, 2021 Classification: Class II Status: Terminated

Product Description

TheraTears Extra (sodium carboxymethylcellulose) 0.25% Lubricant Eye Drops, 30 Sterile Single-Use Vials per box, Akorn Consumer Health, A Division of Akorn, Inc., Ann Arbor, MI 48105. NDC 58790-010-30

Reason for Recall

Lack of Assurance of Sterility

Recalling Firm

Akorn, Inc. — Lake Forest, IL

Classification

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

Product Type

Drugs

Product Quantity

62,331 box

Distribution

Nationwide within theUSA

Code Information

Lot #: 913012, 913013, 913014, Exp. Date 1/31/2023

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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