Eye Irrigating Solution, 4 fl oz (118 mL) bottle, OTC, Distributed by: Rugby Laboratories, 31778 Enterprise Drive, Livonia, MI 48150, Made in Korea, NDC 0536-1083-97
Reported: March 8, 2017 Initiated: September 2, 2016 #D-0497-2017
Product Description
Eye Irrigating Solution, 4 fl oz (118 mL) bottle, OTC, Distributed by: Rugby Laboratories, 31778 Enterprise Drive, Livonia, MI 48150, Made in Korea, NDC 0536-1083-97
Reason for Recall
Lack of assurance of sterility
Details
- Recalling Firm
- United Exchange Corporation
- Units Affected
- 112,320 bottles
- Distribution
- Nationwide, Puerto Rico and Guyana
- Location
- Cerritos, CA
Frequently Asked Questions
What product was recalled? ▼
Eye Irrigating Solution, 4 fl oz (118 mL) bottle, OTC, Distributed by: Rugby Laboratories, 31778 Enterprise Drive, Livonia, MI 48150, Made in Korea, NDC 0536-1083-97. Recalled by United Exchange Corporation. Units affected: 112,320 bottles.
Why was this product recalled? ▼
Lack of assurance of sterility
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 8, 2017. Severity: Moderate. Recall number: D-0497-2017.
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