FDA (Drugs) recall action 93346
The FDA (Drugs) publishes a recall like this one as 6 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 6 pages.
Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
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.
Cardinal Health's LEADER brand Dry Eye Relief eye drops are recalled nationwide due to non-sterility concerns. FDA found insanitary conditions and positive bacterial results from environmental sampling at the manufacturing facility.
Cardinal Health is recalling LEADER brand Eye Irritation Relief drops due to non-sterility concerns. FDA testing found insanitary conditions and positive bacterial results at the manufacturing facility, affecting 11,629 units distributed nationwide.
Cardinal Health is recalling all lots of LEADER brand Lubricant Eye Drops nationwide due to non-sterility. FDA found insanitary conditions and positive bacterial test results from the manufacturing facility.
Cardinal Health is recalling all lots of LEADER brand Dry Eye Relief nationwide due to non-sterility. FDA found insanitary manufacturing conditions and positive bacterial test results.
Cardinal Health is recalling all lots of LEADER brand Lubricant Eye Drops due to non-sterility issues. FDA found insanitary conditions and positive bacterial test results at the manufacturing facility in India.
LEADER brand Lubricant Eye Drops are being recalled nationwide due to non-sterility issues. FDA testing found insanitary conditions and positive bacterial contamination at the manufacturing facility.