Professional Disposables International, Inc. recalls Prevantics (chlorhexidine gluconate and isopropyl alcohol) Swab, 3.15% w/v and 70% v/v, packaged as a) One Swab, 0.034 f
Recalled March 2, 2022 · FDA recall D-0571-2022 · Professional Disposables International
Hazard
cGMP deviations: uncertainty of the adequacy of the validation of the test methods used to manufacture the products. · FDA Class II
Units
a) 160531 cases; b) 16123 cases
Sold at
Product was distributed nationwide in the USA and Puerto Rico.
Description
cGMP deviations: uncertainty of the adequacy of the validation of the test methods used to manufacture the products.
Product
Prevantics (chlorhexidine gluconate and isopropyl alcohol) Swab, 3.15% w/v and 70% v/v, packaged as a) One Swab, 0.034 fl. Oz. (1 mL) Each in a pouch, 100 Individual Swabs per carton, 10 boxes of 100 Individual Swabs per case, REORDER NO. B10800, NDC 10819-1080-1; b) One Swab, 0.034 fl. oz. (1 mL) Each in a pouch, 3000 Individual Swabs per case, REORDER NO. B11400, NDC 10819-1080-2; Professional Disposables International, Inc., Orangeburg, NY 10962-1376.
Manufacturer(s)
Professional Disposables International, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →