Severity
Critical
CriticalClass ITerminated
FDA Drug recall · Reported March 8, 2017
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
Non-Sterility: Direct evidence of contamination for 2 lots based on FDA samples.
United Exchange Corporation recalled EYE WASH, 4 fl oz. (118 mL) bottle, OTC, Distributed by: Major Pharmaceutical, 31778 Ente… — a critical-severity action.
EYE WASH, 4 fl oz. (118 mL) bottle, OTC, Distributed by: Major Pharmaceutical, 31778 Ente… was recalled by United Exchange Corporation in March 8, 2017. Reason: Non-Sterility: Direct evidence of contamination for 2 lots based on FDA samples.. Check the official notice for the remedy. Verify recall #D-0496-2017 with the FDA Drug before acting.
The recall
United Exchange Corporation issued this critical-severity FDA Drug recall — Non-Sterility: Direct evidence of contamination for 2 lots based on FDA samples..
- Critical
- severity level
- Class I
- classification
- March 8, 2017
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0496-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0496-2017) was formally reported on March 8, 2017, with the manufacturer initiating the action on September 2, 2016. It is classified under Critical severity (Class I), with a current status of Terminated. United Exchange Corporation is listed as the recalling firm, operating out of Cerritos, CA. Federal records list the affected scope as 46,080 bottles.
The documented reason for this recall is: Non-Sterility: Direct evidence of contamination for 2 lots based on FDA samples. Distribution data in the federal record shows the product reached: Nationwide, Puerto Rico and Guyana. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 5 from FDA Drug — clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Drugs & Medications recalls over time
Where this recall sits in its category — 14,048 drugs & medications recalls on record
Where this recall sits in the database
Of 100,165 recalls in the database, 23,668 are high severity, 72,097 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger — we do not rank products by risk from raw recall volume.
Affected scope
46,080 bottles
Related Recalls
6
5 from same agency
Product description
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
Non-Sterility: Direct evidence of contamination for 2 lots based on FDA samples.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | D-0496-2017 |
| Date reported | March 8, 2017 |
| Date initiated | September 2, 2016 |
| Recalling firm | United Exchange Corporation |
| Firm location | Cerritos, CA |
| Affected scope | 46,080 bottles |
| Distribution | Nationwide, Puerto Rico and Guyana |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-0496-2017) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting — recall details can be updated.
- This is a Class I (high-risk) recall — stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by United Exchange Corporation. Units affected: 46,080 bottles.
Why was this product recalled? ▼
Non-Sterility: Direct evidence of contamination for 2 lots based on FDA samples.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 8, 2017. Severity: Critical. Recall number: D-0496-2017.
Where was the recalled product distributed? ▼
Distribution: Nationwide, Puerto Rico and Guyana.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0496-2017) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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What to do next
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Data Sources
Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Drug, reported March 8, 2017.
- Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records — no number is typed in by an editor. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of June 2026.