Antiseptic Products Recalled

Professional Disposables International Inc is recalling numerous lots of Prevantics swabs and swabsticks due to deviations from Current Good Manufacturing Practice regulations. The March 2, 2022, US Food and Drug Administration (FDA) Enforcement Report cited “uncertainty of the adequacy of the validation of the test methods used to manufacture the products” as the reason for the recall.

The recall includes the following products, which were distributed throughout the United States and Puerto Rico:

• Prevantics (chlorhexidine gluconate and isopropyl alcohol) Maxi Swabstick, packaged as one swabstick, 0.172 fl oz (5.1 mL) in a pouch, 30 individual swabsticks per carton, 10 boxes of 30 individual swabsticks per case (NDC 10819-4076-4), from lots 12000315 (Exp. 2/22), 12000700 (Exp. 3/22), 12001112 LE (Exp. 6/22), 12001214 (Exp. 7/22), 12001362 (Exp. 8/22), 12001406 (Exp. 8/22), 12001628 (Exp. 9/22), 12001856 (Exp. 10/22), 12002103 (Exp. 12/22), 12002113 (Exp. 1/23), 12100024 (Exp. 1/23), 12100226 (Exp. 2/23), 12100227 (Exp. 2/23), 12100443 (Exp. 3/23), 12100503 (Exp. 3/23), 12100516 (Exp. 4/23), 12100517 (Exp. 4/23), 12100748 (Exp. 5/23), and 12100756 (Exp. 5/23);
• Prevantics (chlorhexidine gluconate and isopropyl alcohol) Maxi Swabstick, packaged as one swabstick, .172 fl oz (5.1 mL) in a pouch, 300 individual swabsticks per case (NDC 10819-4076-3), from lots 12001113 LE (Exp. 6/22), 12001289 (Exp. 7/22), 12001240 (Exp. 7/22), 12002104 (Exp. 12/22), 12100025 (Exp. 1/23), 12100405 (Exp. 3/23), 12100674 (Exp. 4/23), and 12100779 (Exp. 5/23);
• Prevantics (chlorhexidine gluconate and isopropyl alcohol) Swab, packaged as one swab, 0.034 fl oz (1 mL) in a pouch, 100 individual swabs per carton, 10 boxes of 100 individual swabs per case (NDC 10819-1080-1), from lots 12000165, 12000166 and 12000382 (Exp. 2/22); 12000228, 12000381, 12000383, 12000577, 12000578, 12000579, 12000661, and 12000662 (Exp. 3/22); 12000659 and 12000660 (Exp. 4/22); 12001060, 12001061, 12001062, 12001100 LE, and 12001101 LE (Exp. 6/22); 12001233, 12001234, 12001235, and 12001236 (Exp. 7/22); 12001351, 12001394, 12001395, 12001396, 12001397, 12001398, and 12001399 (Exp. 8/22); 12001632,12001633, 12001634, 12001635, and 12001636 (Exp. 9/22); 12001637, 12001638, 12001639, 12001640, 12001641, 12001721, and 12001791 (Exp. 10/22); 12001792, 12001793, 12001794, and 12001962 (Exp. 11/22); 12002039, 12002040, 12100014, 12100015, 12100016, 12100017, 12100035, 12100036, 12100037, 12100074, 12100183, and 12100184 (Exp. 1/23); 12100018, 12100185, 12100186, 12100192, 12100193, 12100194, 12100195, 12100241, 12100242, 12100243, 12100244, 12100245, 12100246, 12100247, and 12100277 (Exp. 2/23); 12100312, 12100313, 12100347, 12100348, and 12100349 (Exp. 3/23); 12100350, 12100351, 12100543, and 12100638 (Exp. 4/23); 12100541, 12100542, 12100639, 12100732, 12100733, 12100753, and 12100754 (Exp. 5/23); 12100755, 12100790, 12100791, and 12100824 (Exp. 6/23);
• Prevantics (chlorhexidine gluconate and isopropyl alcohol) Swab, packaged as one swab, 0.034 fl oz (1 mL) in a pouch, 3000 individual swabs per case (NDC 10819-1080-2), from lots 12000194 and 12000195 (Exp. 2/22); 12000500, 12000570, 12000594, and 12000698 (Exp. 3/22); 12001058, 12001059, 12001069, 12001108 LE, 12001109 LE, and 12001110 LE (Exp. 6/22); 12001111 LE, 12001225, 12001226, 12001227, 12001228, 12001229, and 12001230 (Exp. 7/22); 12001393 and 12001522 (Exp. 8/22); 12001734, 12001735, 12001736, and 12001737 (Exp. 10/22); 12001854 (Exp. 11/22); 12002033, 12002035, 12002045, and 12002046 (Exp. 12/22); 12100019, 12100020, 12100021, 12100022, 12100096, 12100097, 12100098, and 12100099 (Exp. 1/23); 12100196, 12100197, 12100251, 12100252, 12100253, 12100254, 12100255, 12100256, 12100257, and 12100346 (Exp. 2/23); 12100363, 12100364, 12100365, and 12100366 (Exp. 3/23); 12100518, 12100519, 12100520, and 12100521 (Exp. 4/23); and 12100691 and 12100693 (Exp. 5/23);
• Prevantics (chlorhexidine gluconate and isopropyl alcohol) swabstick, packaged as one swabstick, .054 fl oz (1.6 mL) in a pouch (NDC 10819-4077-1), 50 individual swabsticks per carton, 10 boxes of 50 individual swabsticks per case (NDC 10819-4077-4), from lots 12000203 and 12000204 (Exp. 3/22); 12001114 LE (Exp. 6/22); 12001115 LE and 12001117 LE (Exp. 7/22); 12001313, 12001407, and 12001408, (Exp. 8/22); 12001498, 12001499, 12001500, 12001629, and 12001630 (Exp. 9/22); 12002070 and 12002114 (Exp. 12/22); 12100106, 12100107, and 12100223 (Exp. 2/23); 12100224, 12100225, 12100354, and 12100513 (Exp. 3/23); 12100514, 12100515, 12100605, and 12100628 (Exp. 4/23); and 12100629 and 12100630 (Exp. 5/23);
• Prevantics (chlorhexidine gluconate and isopropyl alcohol) swabstick, packaged as one swabstick, .054 fl oz (1.6 mL) in a pouch, 500 individual swabsticks per case (NDC 10819-4077-2), from lots 12000332 (Exp. 2/22); 12000484 (Exp. 3/22); 12001116 LE (Exp. 7/22); 12001312 (Exp. 8/22); 12001730 (Exp. 10/22); 12002071 and 12100105 (Exp. 1/23); 12100222 (Exp. 3/23); and 12100635 and 12100636 (Exp. 6/23); and
• Prevantics (chlorhexidine gluconate and isopropyl alcohol) swabstick, packaged as one swabstick, .054 fl oz (1.6 mL) in a pouch, 500 individual swabsticks per case (NDC 10819-4077-3), from lots 12000728 (Exp. 4/22); 12001119 LE (Exp. 7/22); 12001631 (Exp. 10/22); 12001811 (Exp. 11/22); 12002115 and 12002116 (Exp. 1/23); 12100221 (Exp. 2/23); 12100633 (Exp. 5/23);  and 12100634, 12100774, and 12100817 (Exp. 6/23).

Professional Disposables International voluntarily initiated the recall February 4, 2022. On February 18, 2022, the FDA designated the recall Class II, communicating use of the products may cause temporary or medically reversible adverse health consequences or a remote possibility of serious harm.

Prevantics swabs and swabsticks are antiseptic products used to prepare a patient’s skin prior to an injection or surgery.