Eye Irrigating Solution recalled over sterility concerns
- Recall date
- September 2, 2016
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- United Exchange Corporation recalls Eye Irrigating Solution, 4 fl oz (118 mL) bottle, OTC, Distributed by: Rugby Laboratories, 31778 Enterprise Drive, Livo…
- Recall number
- D-0497-2017
- FDA classification
- Class II
- Brand / firm
- United Exchange Corporation
- Sold / distributed
- Nationwide, Puerto Rico and Guyana
Why it was recalled
Lack of assurance of sterility
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What 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
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