Professional Disposables International, Inc. recalls Prevantics (chlorhexidine gluconate and isopropyl alcohol) Swabstick, 3.15% w/v and 70% v/v, packaged as a) One Swabstic
Recalled March 2, 2022 · FDA recall D-0572-2022 · 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) 28201 cases; b) 7579 cases; c) 8882 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) Swabstick, 3.15% w/v and 70% v/v, packaged as a) One Swabstick, 0.054 fl. oz. (1.6 mL) Each in a pouch, NDC 10819-4077-1; 50 Individual Swabsticks per carton, 10 boxes of 50 Individual Swabsticks per case, REORDER NO. S40750, NDC 10819-4077-4; b) One Swabstick, 0.054 fl. Oz. (1.6 mL) Each in a pouch, 500 Individual Swabsticks per case, REORDER NO. S32450, NDC 10819-4077-2; c) One Swabstick, 0.054 fl. Oz. (1.6 mL) Each in a pouch, 500 Individual Swabsticks per case, REORDER NO. S42850, NDC 10819-4077-3; 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 →