FDA Drug recall D-0861-2020
CVS Health Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes, Distributed By: CVS Pharmacy Inc
- FDA Drug
- Class III
- terminated
- Published 2020-03-04
On 2020-03-04 the FDA classified a Class III recall of CVS Health Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes, Distributed By: CVS Pharmacy Inc 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-0861-2020 |
| 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
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
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 #:8G50A, Exp. Date 06/2021 |
|---|
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-0861-2020%22
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