Professional Disposables International, Inc. recalls Prevantics (chlorhexidine gluconate and isopropyl alcohol) Maxi Swabstick, 3.15% w/v and 70% v/v, packaged as a) One Max
Recalled March 2, 2022 · FDA recall D-0570-2022 · 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) 9518 cases; b) 3347 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) Maxi Swabstick, 3.15% w/v and 70% v/v, packaged as a) One Maxi Swabstick, 0.172 fl. Oz. (5.1 mL) Each in a pouch, 30 Individual Maxi Swabsticks per carton, 10 boxes of 30 Individual Swabsticks per case, NDC 10819-4076-4, REORDER NO. S41950; b) One Maxi Swabstick, 0.172 fl. Oz. (5.1 mL) Each in a pouch, 300 Individual Swabsticks per case, NDC 10819-4076-3, REORDER NO. S27350; 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 →