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.

Class I - Dangerous

💊 Drugs Recalled: February 4, 2022 Professional Disposables International Other Drugs Nationwide

What Should You Do?

Check if you have this product:
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
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:: Professional Disposables International, Inc.
Reason for Recall:: cGMP deviations: uncertainty of the adequacy of the validation of the test methods used to manufacture the products.
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: terminated

Product Information

Full Description:

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.

Product Codes/Lot 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