Prevantics Swab (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) Swab, 3.15% w/v and 70% v/v, packaged as a) One Swab, 0.034 fl. Oz. (1 mL) Each in a pouch, 100 Individual Swabs per carton, 10 boxes of 100 Individual Swabs per case, REORDER NO. B10800, NDC 10819-1080-1; b) One Swab, 0.034 fl. oz. (1 mL) Each in a pouch, 3000 Individual Swabs per case, REORDER NO. B11400, NDC 10819-1080-2; Professional Disposables International, Inc., Orangeburg, NY 10962-1376.
Brand
Professional Disposables International, Inc.
Lot Codes / Batch Numbers
Lot #: a) 12000165, 12000166, 12000382, Exp Feb 2022, 12000228, 12000381, 12000383, 12000577, 12000578, 12000579, 12000661, 12000662, Exp Mar 2022, 12000659, 12000660, Exp Apr 2022, 12001060, 12001061, 12001062, 12001100 LE, 12001101 LE, Exp Jun 2022, 12001233, 12001234, 12001235, 12001236, Exp Jul 2022, 12001351, 12001394, 12001395, 12001396, 12001397, 12001398, 12001399, Exp Aug 2022, 12001632, 12001633, 12001634, 12001635, 12001636, Exp Sep 2022, 12001637, 12001638, 12001639, 12001640, 12001641, 12001721, 12001791, Exp Oct 2022, 12001792, 12001793, 12001794, 12001962, Exp Nov 2022, 12002039, 12002040, 12100014, 12100015, 12100016, 12100017, 12100035, 12100036, 12100037, 12100074, 12100183, 12100184, Exp Jan 2023, 12100018, 12100185, 12100186, 12100192, 12100193, 12100194, 12100195, 12100241, 12100242, 12100243, 12100244, 12100245, 12100246, 12100247, 12100277, Exp Feb 2023, 12100312, 12100313, 12100347, 12100348, 12100349, Exp Mar 2023, 12100350, 12100351, 12100543, 12100638, Exp Apr 2023, 12100541, 12100542, 12100639, 12100732, 12100733, 12100753, 12100754, Exp May 2023, 12100755, 12100790, 12100791, 12100824, Exp Jun 2023, b) 12000194, 12000195, Exp Feb 2022, 12000500, 12000570, 12000594, 12000698, Exp Mar 2022, 12001058, 12001059, 12001069, 12001108 LE, 12001109 LE, 12001110 LE, Exp Jun 2022, 12001111 LE, 12001225, 12001226, 12001227, 12001228, 12001229, 12001230, Exp Jul 2022, 12001393, 12001522, Exp Aug 2022, 12001734, 12001735, 12001736, 12001737, Exp Oct 2022, 12001854, Exp Nov 2022, 12002033, 12002035, 12002045, 12002046, Exp Dec 2022, 12100019, 12100020, 12100021, 12100022, 12100096, 12100097, 12100098, 12100099, Exp Jan 2023, 12100196, 12100197, 12100251, 12100252, 12100253, 12100254, 12100255, 12100256, 12100257, 12100346, Exp Feb 2023, 12100363, 12100364, 12100365, 12100366, Exp Mar 2023, 12100518, 12100519, 12100520, 12100521, Exp Apr 2023, 12100691, 12100693, Exp May 2023
Products Sold
Lot #: a) 12000165, 12000166, 12000382, Exp Feb 2022; 12000228, 12000381, 12000383, 12000577, 12000578, 12000579, 12000661, 12000662, Exp Mar 2022; 12000659, 12000660, Exp Apr 2022; 12001060, 12001061, 12001062, 12001100 LE, 12001101 LE, Exp Jun 2022; 12001233, 12001234, 12001235, 12001236, Exp Jul 2022; 12001351, 12001394, 12001395, 12001396, 12001397, 12001398, 12001399, Exp Aug 2022; 12001632,12001633, 12001634, 12001635, 12001636, Exp Sep 2022; 12001637, 12001638, 12001639, 12001640, 12001641, 12001721, 12001791, Exp Oct 2022; 12001792, 12001793, 12001794, 12001962, Exp Nov 2022; 12002039, 12002040, 12100014, 12100015, 12100016, 12100017, 12100035, 12100036, 12100037, 12100074, 12100183, 12100184, Exp Jan 2023; 12100018, 12100185, 12100186, 12100192, 12100193, 12100194, 12100195, 12100241, 12100242, 12100243, 12100244, 12100245, 12100246, 12100247, 12100277, Exp Feb 2023; 12100312, 12100313, 12100347, 12100348, 12100349, Exp Mar 2023; 12100350, 12100351, 12100543, 12100638, Exp Apr 2023; 12100541, 12100542, 12100639, 12100732, 12100733, 12100753, 12100754, Exp May 2023; 12100755, 12100790, 12100791, 12100824, Exp Jun 2023; b) 12000194, 12000195, Exp Feb 2022; 12000500, 12000570, 12000594, 12000698, Exp Mar 2022; 12001058, 12001059, 12001069, 12001108 LE, 12001109 LE, 12001110 LE, Exp Jun 2022; 12001111 LE, 12001225, 12001226, 12001227, 12001228, 12001229, 12001230, Exp Jul 2022; 12001393, 12001522, Exp Aug 2022; 12001734, 12001735, 12001736, 12001737, Exp Oct 2022; 12001854, Exp Nov 2022; 12002033, 12002035, 12002045, 12002046, Exp Dec 2022; 12100019, 12100020, 12100021, 12100022, 12100096, 12100097, 12100098, 12100099, Exp Jan 2023; 12100196, 12100197, 12100251, 12100252, 12100253, 12100254, 12100255, 12100256, 12100257, 12100346, Exp Feb 2023; 12100363,12100364, 12100365, 12100366, Exp Mar 2023; 12100518, 12100519, 12100520, 12100521, Exp Apr 2023; 12100691, 12100693, Exp May 2023
Professional Disposables International, Inc. is recalling Prevantics (chlorhexidine gluconate and isopropyl alcohol) Swab, 3.15% w/v and 70% v/v, packaged as 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