FDA (Drugs) recall action 86427
The FDA (Drugs) publishes a recall like this one as 5 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 5 pages.
CGMP Deviations: hand sanitizers were recalled because they were manufactured in the same facility as another hand sanitizer product with sub-potent ethanol levels.
Sub-Potent Drug; Killz GERMz was recalled due to sub-potent results. Testing revealed ethanol levels as low as 62% while labelled claim is 70%.
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.
Genesis Partnership Company SA is recalling 5,040 bottles of hand sanitizer gel due to manufacturing deviations in a facility that produced sub-potent products.
Genesis Partnership Company SA is recalling 15,000 bottles of Genesis Hand Sanitizer Gel due to manufacturing deviations in a facility that produced sub-potent products.
Genesis Partnership Company SA is recalling 33,480 bottles of Panagel Hand Sanitizer due to CGMP deviations and potential sub-potent ethanol levels.
Genesis Partnership Company SA is recalling Killz Germz Hand Sanitizer because testing showed ethanol levels as low as 62%, below the labeled 70% claim.
Genesis Partnership Company SA is recalling Killz Germz Hand Sanitizer because testing showed ethanol levels as low as 62%, below the labeled 70% claim.