CVS Health Preservative Free Lubricant Eye Drops — Class II drug recall D-0378-2020
Completed recall by Altaire Pharmaceuticals, Inc., reported 2019-11-27, distributed nationwide. Lack of Assurance of Sterility
| Recall number | D-0378-2020 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Altaire Pharmaceuticals, Inc., Aquebogue, NY, United States |
| Recall initiated | 2019-07-02 |
| Classified | 2019-11-15 |
| Reported by FDA | 2019-11-27 |
| Distributed | Nationwide (US) |
| Quantity | 45,864 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 00050428310106 |
| Lot numbers | 04/20SFC, 06/20SFJ, 06/20SGI, 07/19RHN, 07/20, 08/19RIH, 09/19RJP, 10/19RKN, 11/19SDC |
| Model numbers | 495334 |
Product
CVS Health Preservative Free Lubricant Eye Drops (Carboxymethycellulose Sodium 0.5% Glycerin 0.9%) Sensitive Solution, Item #495334, 60 Sterile Single-Use Containers, 0.02 fl. oz. (0.6 mL) each, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 31010 6
Reason for recall
Lack of Assurance of Sterility
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-0378-2020. 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.