Professional Disposables International, Inc.: 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

Is my product affected?

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;

• Brand PREVANTICS MAXI SWABSTICK

Check against the official notice below — it lists the full affected range.

What happened

Professional Disposables International, Inc. is recalling Prevantics Maxi Swabsticks containing chlorhexidine gluconate and isopropyl alcohol due to current Good Manufacturing Practice (cGMP) deviations. Specifically, there is uncertainty about whether the test methods used to manufacture the products were adequately validated. The recalled product was distributed nationwide in the USA and Puerto Rico, with approximately 9,518 cases of one configuration and 3,347 cases of another configuration affected across multiple lot numbers with expiration dates ranging from February 2022 through May 2023.

The recall record does not specify a remedy for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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

Details from the source

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) 9518 cases; b) 3347 cases Lot/code info: Lot #: a) 12000315, Exp Feb 2022; 12000700, Exp Mar 2022; 12001112 LE, Exp Jun 2022; 12001214, Exp Jul 2022; 12001362, 12001406, Exp Aug 2022; 12001628, Exp Sep 2022; 12001856, Exp Oct 2022; 12002103, Exp Dec 2022; 12002113, 12100024, Exp Jan 2023; 12100226, 12100227, Exp Feb 2023; 12100443, 12100503, Exp Mar 2023; 12100516, 12100517, Exp Apr 2023; 12100748, 12100756, Exp May 2023; b) 12001113 LE, Exp Jun 2022; 12001289, 12001240, Exp Jul 2022; 12002104, Exp Dec 2022; 12100025, Exp Jan 2023; 12100405, Exp Mar 2023; 12100674, Exp Apr 2023; 12100779, Exp May 2023

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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