FDA (Drugs) recall action 93339
The FDA (Drugs) publishes a recall like this one as 2 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 2 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.
FDA recalls Polyvinyl Alcohol 1.4% Lubricating Eye Drops nationwide due to non-sterile manufacturing conditions found during inspection.
Rugby Laboratories' Lubricating Tears Eye Drops are being recalled nationwide due to non-sterility. FDA found insanitary conditions and positive bacterial test results at the manufacturing facility.