The Recall Desk
LowFDA (Drugs)·D-0861-2020·Announced 2020-03-04

CVS Health Sodium Chloride Ophthalmic Ointment Recalled for Particulate Matter

Akorn, Inc. is recalling CVS Health Sodium Chloride Ophthalmic Ointment USP, 5%, due to the presence of brown spots identified as tin with trace copper inside the tubes.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The hazard involves particulate matter from tube construction materials, which is a minor quality issue without reported injuries.

Plain-English summary

Akorn, Inc. is recalling CVS Health Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes (NDC 59779-303-01). The product is distributed by CVS Pharmacy Inc. The specific lot affected is Lot #8G50A with an expiration date of 06/2021.

The recall was initiated due to the presence of particulate matter. Brown spots were observed on the inside of the product tubes. These spots were identified as tin with trace copper, which are the base materials of construction for the tube.

The product was distributed nationwide within the United States and Puerto Rico. Consumers should check their inventory for the specific lot number and expiration date listed above. If the product matches the recalled lot, consumers should stop using it and contact their healthcare provider or the recalling firm for instructions on disposal or replacement.

The recalled product

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
Manufacturer
Akorn, Inc.
Category
Drug — Ophthalmic
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot #:8G50A
  • Exp. Date 06/2021

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 3 recalled by Akorn, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Related recalls

Same manufacturer · Akorn, Inc.

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Same hazard · particulate matter

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