FDA Drug recall D-0859-2020
Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes, Manufactured by: Akorn, Inc., Lake Forest, IL 60045
- FDA Drug
- Class III
- terminated
- Published 2020-03-04
On 2020-03-04 the FDA classified a Class III recall of Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes, Manufactured by: Akorn, Inc., Lake Forest, IL 60045 by Akorn, citing 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….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0859-2020 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2020-02-21 |
| Published | 2020-03-04 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Akorn |
| Distribution | US |
Product
Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-622-35
Reason
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.
Identifiers
| code_info | 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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0859-2020%22
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