Prevantics Maxi Swabstick (PDI) – Manufacturing Method Uncertainty (2022)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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 1
Brand
Professional Disposables International, Inc.
Lot Codes / Batch Numbers
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
Products Sold
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
Professional Disposables International, Inc. is recalling Prevantics (chlorhexidine gluconate and isopropyl alcohol) Maxi Swabstick, 3.15% w/v and 70% v/v, pa due to cGMP deviations: uncertainty of the adequacy of the validation of the test methods used to manufacture the products.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
cGMP deviations: uncertainty of the adequacy of the validation of the test methods used to manufacture the products.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026