FDAClass IIIMarch 4, 2020

CVS Health Sodium Chloride Ophthalmic Ointment USP recall: Particulate Matter

CVS Health Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes, Distributed By: CVS Pharmacy Inc. One CVS Drive, Woonsocket, RI 02895, NDC 59779-303-01

Why was CVS Health Sodium Chloride Ophthalmic Ointment USP recalled?

Presence of Particulate Matter: Brown spots observed on the inside of the tube of product, identified as tin with trace copper, which are the base of the materials of construction for the tube.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #:8G50A, Exp. Date 06/2021

Product
CVS Health Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes, Distributed By: CVS Pharmacy Inc. One CVS Drive, Woonsocket, RI 02895, NDC 59779-303-01
Recalling firm
Akorn, Inc.
Quantity
N/A
Distribution
Nationwide within United States and Puerto Rico
Recall date
March 4, 2020
Classification
Class III
Status
Terminated
Agency
FDA (drug)
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