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.

Reason: cGMP deviations: uncertainty of the adequacy of the validation of the test methods used to manufacture the products.

Code information: Lot #: a) 12000203, 12000204, Exp Mar 2022; 12001114 LE, Exp Jun 2022; 12001115 LE, 12001117 LE, Exp Jul 2022; 12001313, 12001407, 12001408, Exp Aug 2022; 12001498, 12001499, 12001500, 12001629, 12001630, Exp Sep 2022; 12002070, 12002114, Exp Dec 2022; 12100106, 12100107, 12100223, Exp Feb 2023; 12100224, 12100225, 12100354, 12100513, Exp Mar 2023; 12100514, 12100515, 12100605, 12100628, Exp Apr 2023; 12100629, 12100630, Exp May 2023; b) 12000332, Exp Feb 2022; 12000484, Exp Mar 2022; 12001116 LE, Exp Jul 2022; 12001312, Exp Aug 2022; 12001730, Exp Oct 2022; 12002071, 12100105, Exp Jan 2023; 12100222, Exp Mar 2023; 12100635, 12100636, Exp Jun 2023; c) 12000728, Exp Apr 2022; 12001119 LE, Exp Jul 2022; 12001631, Exp Oct 2022; 12001811, Exp Nov 2022; 12002115, 12002116, Exp Jan 2023; 12100221, Exp Feb 2023; 12100633, Exp May 2023; 12100634, 12100774, 12100817, Exp Jun 2023

Distribution pattern: Product was distributed nationwide in the USA and Puerto Rico.