CLASS I Drug recall · Reported 8 Mar 2017 · FDA Enforcement Report
EYE WASH recalled by United Exchange
United Exchange is recalling EYE WASH, distributed nationwide in the US. The recall was initiated on 2 Sep 2016 and the FDA has classified it as Class I.
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-0496-2017
- FDA event ID
- 75092
- Recalling firm
- United Exchange, Cerritos, CA
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 2 Sep 2016
- FDA classified
- 27 Feb 2017
- Reported
- 8 Mar 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Sterility
Timeline
| 2 Sep 2016 | Recall initiated by company | |
| 27 Feb 2017 | Classified by FDA | +178 days |
| 8 Mar 2017 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Non-Sterility: Direct evidence of contamination for 2 lots based on FDA samples.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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
Where it was distributed
Nationwide, Puerto Rico and Guyana
Questions about this recall
Is EYE WASH recalled?
Yes. United Exchange recalled EYE WASH on 2 Sep 2016. The recall is Class I and its status is Terminated. Recall number D-0496-2017.
Why was it recalled?
Non-Sterility: Direct evidence of contamination for 2 lots based on FDA samples.
Which lots are affected?
Lot # G15905, G15907, Exp 10/2018
Where was it sold?
Nationwide, Puerto Rico and Guyana
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 I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from United Exchange
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | EYE WASH recalled by United Exchange | United Exchange | Sterility | Nationwide |
| Drug | CLASS II | Eye Irrigating Solution recalled by United Exchange | United Exchange | Sterility | Nationwide |
| Drug | CLASS II | Eye Wash recalled by United Exchange | United Exchange | Sterility | Nationwide |