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Sodium Chloride Ophthalmic Ointment USP, 5%, Sterile, Net Wt 3.5 g (1/8 oz) tube, Mfg by: Akorn, ...

FDA Recall #D-1496-2022 — Class II — August 31, 2022

Recall #D-1496-2022 Date: August 31, 2022 Classification: Class II Status: Terminated

Product Description

Sodium Chloride Ophthalmic Ointment USP, 5%, Sterile, Net Wt 3.5 g (1/8 oz) tube, Mfg by: Akorn, Inc., Lake Forest , IL 600405, NDC 17478-622-35

Reason for Recall

cGMP Deviations: Turbidity discovered in Artificial Tears Ointment during sterility testing. Scope expanded to include other lots and products which potentially share the same root cause.

Recalling Firm

Akorn, Inc. — Gurnee, IL

Classification

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

Product Type

Drugs

Product Quantity

48,636 tubes

Distribution

USA nationwide

Code Information

Lot#: 9J58A, 9J58B, Exp 8/31/2022

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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