Sodium Chloride Ophthalmic Ointment (Akorn) – Particulate Matter (2020)
Class III: A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences
Class III recall indicates unlikely adverse health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-622-35
Brand
Akorn, Inc.
Lot Codes / Batch Numbers
Lot #: 8B66A, Exp. Date 01/2021, Lot 8C91A, Exp. Date 02/2021, Lots 8F07A, 8F16A, Exp. Date 05/2021, Lot 8F13A, Exp. Date 07/2021.
Products Sold
Lot #: 8B66A, Exp. Date 01/2021; Lot 8C91A, Exp. Date 02/2021; Lots 8F07A, 8F16A, Exp. Date 05/2021; Lot 8F13A, Exp. Date 07/2021.
Akorn, Inc. is recalling Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes, Manufactured by: Akorn, Inc., Lake Forest due to 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 . This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026