EYE WASH — Class II drug recall D-0499-2017
Terminated recall by United Exchange Corporation, reported 2017-03-08, distributed nationwide. Lack of assurance of sterility
| Recall number | D-0499-2017 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | United Exchange Corporation, Cerritos, CA, United States |
| Recall initiated | 2016-09-02 |
| Classified | 2017-02-27 |
| Reported by FDA | 2017-03-08 |
| Terminated | 2017-06-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | GY |
| Quantity | 190,710 bottles |
| Reason classes | sterility |
| NDC | 00904-6491-20 |
| Lot numbers | G15906, G15910, G15911, G15912, G16901, G16902, G16903, G16905, G16906, G16907, G16910, G16911 |
| Expiration dates | 2018-10, 2018-11, 2019-01, 2019-02, 2019-03 |
Product
EYE WASH, 4 fl oz. (118 mL) bottle, OTC, Distributed by: Major Pharmaceutical, 31778 Enterprise Drive, Livonia, MI 48150, Made in Korea, NDC 0904-6491-20
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-0499-2017. 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.