CVS Health Sodium Chloride Ophthalmic Ointment USP — Class III drug recall D-0861-2020
Terminated recall by Akorn, Inc., reported 2020-03-04, distributed nationwide. Presence of Particulate Matter: Brown spots observed on the inside of the tube of product, identified as tin w
| Recall number | D-0861-2020 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Akorn, Inc., Lake Forest, IL, United States |
| Recall initiated | 2020-02-21 |
| Classified | 2020-02-27 |
| Reported by FDA | 2020-03-04 |
| Terminated | 2022-07-28 |
| Distributed | Nationwide (US) |
| Reason classes | specification failure |
| NDC | 59779-0303-01 |
| Lot numbers | 8G50A |
| Expiration dates | 2021-06 |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0861-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.