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.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
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
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.
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