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-
Check against the official notice below — it lists the full affected range.
Professional Disposables International, Inc. is recalling Prevantics chlorhexidine gluconate and isopropyl alcohol swabsticks due to cGMP deviations related to uncertainty about the adequacy of validation of the test methods used to manufacture the products. The recalled product was distributed nationwide in the USA and Puerto Rico, consisting of approximately 44,662 total cases across three packaging configurations with various lot numbers and expiration dates ranging from February 2022 through June 2023.
The recall includes specific lot numbers identified in the recall record, with products packaged as individual 0.054 fl. oz. (1.6 mL) swabsticks. The recall source does not specify a remedy or required consumer action.
Written by software from the official notice below. Not reviewed by a lawyer.
cGMP deviations: uncertainty of the adequacy of the validation of the test methods used to manufacture the products.
Reason for recall: cGMP deviations: uncertainty of the adequacy of the validation of the test methods used to manufacture the products. Distribution: Product was distributed nationwide in the USA and Puerto Rico. Quantity: a) 28201 cases; b) 7579 cases; c) 8882 cases Lot/code info: 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
Official record: FDA (Drug enforcement) ↗
Republished from the official source above; details can change — the source record controls.