FDA (Drugs) recall action 74819
The FDA (Drugs) publishes a recall like this one as 3 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 3 pages.
CGMP Deviations: potential contamination of products manufactured on the same equipment and lines as the contaminated product.
Microbial Contamination of Non-Sterile Products: contamination with the bacteria, Burkholderia cepacia.
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.
Sage Products LLC is recalling 2% Chlorhexidine Gluconate Cloth due to CGMP deviations and potential contamination. The product was distributed nationwide and internationally.
Sage Products LLC is recalling Comfort Shield Barrier Cream Cloths because they are contaminated with Burkholderia cepacia bacteria.
Sage Products LLC is recalling Comfort Shield Barrier Cream Cloths due to CGMP deviations and potential contamination on shared equipment.