CLASS III Drug recall · Reported 4 Mar 2020 · FDA Enforcement Report
CVS Health Sodium Chloride Ophthalmic Ointment USP, 5% tubes recalled
Akorn is recalling CVS Health Sodium Chloride Ophthalmic Ointment USP, 5% tubes, distributed nationwide in the US. The recall was initiated on 21 Feb 2020 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0861-2020
- FDA event ID
- 85018
- Recalling firm
- Akorn, Lake Forest, IL
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 21 Feb 2020
- FDA classified
- 27 Feb 2020
- Reported
- 4 Mar 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Eye Drops
Timeline
| 21 Feb 2020 | Recall initiated by company | |
| 27 Feb 2020 | Classified by FDA | +6 days |
| 4 Mar 2020 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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
Where it was distributed
Nationwide within United States and Puerto Rico
Stores named: CVS
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Lot #:8G50A, Exp. Date 06/2021
Where was it sold?
Nationwide within United States and Puerto Rico
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 85018This product is part of a recall event; the main page for the event is Well at Walgreens Sodium Chloride Ophthalmic Ointment USP, 5% tubes recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | Well at Walgreens Sodium Chloride Ophthalmic Ointment USP, 5% tubes recalled | Akorn | Particulate Matter | Nationwide | |
| CLASS III | Sodium Chloride Ophthalmic Ointment USP, 5% tubes recalled by Akorn | Akorn | Particulate Matter | Nationwide |
More recalls from Akorn
All 192| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Timolol Maleate Ophthalmic Solution recalled by Akorn | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | Calcipotriene Topical Solution, 0.005% (Scalp Solution) recalled | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | Midazolam Injection, USP, 50 mg/ (5mg/mL) recalled by Akorn | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | Lidocaine Ointment USP, 5%, 1 tubes recalled by Akorn | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | Midazolam Injection, USP 2mg recalled by Akorn | Akorn | Potency & Assay | Nationwide |