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
Reported: March 8, 2017 Initiated: September 2, 2016 #D-0496-2017
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.
Details
- Recalling Firm
- United Exchange Corporation
- Units Affected
- 46,080 bottles
- Distribution
- Nationwide, Puerto Rico and Guyana
- Location
- Cerritos, CA
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.
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