United Exchange Recalls Non-Sterile Eye Wash Bottles Nationwide
United Exchange Corporation is recalling 46,080 bottles of Eye Wash due to direct evidence of non-sterility contamination in two lots.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of 5 according to the rubric.
Plain-English summary
United Exchange Corporation is recalling 46,080 bottles of 4 fl oz (118 mL) Eye Wash, OTC, distributed by Major Pharmaceutical. The product is made in Korea and carries NDC 0904-6491-20. The recall covers Lot # G15905 and Lot # G15907, both with an expiration date of 10/2018.
The recall was initiated because of direct evidence of contamination indicating non-sterility for two lots, based on FDA samples. The agency has classified this recall as Class I.
The affected products were distributed nationwide, in Puerto Rico, and in Guyana. Consumers should stop using the recalled eye wash and contact the distributor or manufacturer for instructions on return or disposal.
The recalled product
- Product
- 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
- Manufacturer
- United Exchange Corporation
- Category
- Drug — Ophthalmic
- Affected units
- 46,080
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 (3)
- Lot # G15905
- G15907
- Exp 10/2018
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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