United Exchange Eye Wash Recalled Due to Lack of Sterility Assurance
United Exchange Corporation is recalling 77,184 bottles of Eye Wash because the product lacks assurance of sterility. The recall covers specific lots distributed nationwide, in Puerto Rico, and in Guyana.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II. According to the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects, are rated Severe. While the source text does not explicitly mention hospitalizations, the lack of sterility assurance in an eye wash product poses a significant risk of infection, aligning with the Severe criteria for Class II recalls with significant potential harm.
Plain-English summary
United Exchange Corporation is voluntarily recalling 77,184 bottles of Eye Wash, 4 fl oz (118 mL), OTC. The recall is being conducted because the product lacks assurance of sterility. The affected product is made in Korea and distributed by United Exchange Corp. in Cerritos, California.
The recall includes specific lot numbers G15901, G15902, G15903, G15904 (Expiration 07/31/2018) and G16909 (Expiration 05/30/2019). The product was distributed nationwide, in Puerto Rico, and in Guyana. The UPC code for the product is 780707005828.
Consumers should check their Eye Wash bottles for the affected lot numbers and expiration dates listed above. If the product matches the recall description, consumers should stop using it and contact United Exchange Corporation for further instructions or a refund.
The recalled product
- Product
- Eye Wash, 4 fl oz (118 mL) bottle, OTC, Distributed by: United Exchange Corp., 17211 Valley View Ave., Cerritos, CA 90703, Made in Korea, UPC Code: 780707005828
- Manufacturer
- United Exchange Corporation
- Category
- Drug — Ophthalmic
- Hazard
- Affected units
- 77,184
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- Lot # G15901
- G15902
- G15903
- G15904
- Exp 07/31/2018
- G16909
- Exp 05/30/2019
Distribution
Part of a larger recall action
This product is one of 4 recalled by United Exchange Corporation under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
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