FDA (Drugs) recall action 89547
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: uncertainty of the adequacy of the validation of the test methods used to manufacture the products.
The agency’s own wording, quoted from the enforcement report.
Professional Disposables International, Inc. is recalling Prevantics Swab (chlorhexidine gluconate and isopropyl alcohol) due to cGMP deviations involving inadequate validation of manufacturing test methods. The product was distributed nationwide in the USA and Puerto Rico.
Professional Disposables International is recalling Prevantics Maxi Swabstick (chlorhexidine gluconate and isopropyl alcohol) due to unvalidated test methods used during manufacturing. The company has not reported any illnesses or injuries.
Professional Disposables International is recalling Prevantics Swabstick (chlorhexidine gluconate and isopropyl alcohol) products nationwide due to uncertain validation of the test methods used during manufacturing.