FDA (Drugs) recall action 75092
The FDA (Drugs) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.
Non-Sterility: Direct evidence of contamination for 2 lots based on FDA samples.
Lack of assurance of sterility
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
United Exchange Corporation is recalling 46,080 bottles of Eye Wash due to direct evidence of non-sterility contamination in two lots.
United Exchange Corporation is recalling 190,710 bottles of Eye Wash due to a lack of assurance of sterility. The product was distributed nationwide, in Puerto Rico, and in Guyana.
United Exchange Corporation is recalling 112,320 bottles of Eye Irrigating Solution because the product lacks assurance of sterility.
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.