Prevantics Swab Recall: Cgmp Validation Issues
Recalled Prevantics swabs (3.15% chlorhexidine gluconate) due to uncertainty in test method validation. Check NDC 10819-1080-1 or 10819-1080-2 for affected lots.
Lower-risk recall
cGMP deviations: uncertainty of the adequacy of the validation of the test methods used to manufacture the products.
Contact the company
What happened, in plain English
Professional Disposables International is recalling Prevantics swabs because manufacturing test methods weren't validated properly. This could mean the swabs don't work as intended for medical use. Read more at govinfonow.com/recall/35239-prevantics-swab-recall-cgmp-validation-issues.
Source Summary by GovInfoNow · govinfonow.com/recall/35239-prevantics-swab-recall-cgmp-validation-issues · Updated August 18, 2026 · FDA enforcement record: FDA #D-0571-2022
Cite this page
“Prevantics Swab Recall: Cgmp Validation Issues.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/35239-prevantics-swab-recall-cgmp-validation-issues. Based on FDA recall #D-0571-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0571-2022%22&limit=1).
Why it’s dangerous
The swabs were manufactured using test methods that weren't properly validated. This uncertainty means the product might not work as intended for medical use, potentially affecting treatment effectiveness.
Who’s affected
Healthcare professionals and medical facilities using the Prevantics swabs. Patients using these swabs for medical procedures may be at risk if the product doesn't function correctly.
How to tell if you have this one
Check for NDC codes 10819-1080-1 or 10819-1080-2 on the packaging. Look for specific lot numbers listed in the recall notice, which include dates from February 2022 through May 2023.
- Brand
Professional Disposables International- Category
Drug
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Product was distributed nationwide in the USA and Puerto Rico.
| Recall number | Product, codes & lots | Quantity | NDC |
|---|---|---|---|
| D-0570-2022 | 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 10962-1376.; 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 | a) 9518 cases; b) 3347 cases | 10819-4076-4, 10819-4076-3 |
| D-0571-2022 | 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.; 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 | a) 160531 cases; b) 16123 cases | 10819-1080-1, 10819-1080-2 |
| D-0572-2022 | Prevantics (chlorhexidine gluconate and isopropyl alcohol) Swabstick, 3.15% w/v and 70% v/v, packaged as a) One Swabstick, 0.054 fl. oz. (1.6 mL) Each in a pouch, NDC 10819-4077-1; 50 Individual Swabsticks per carton, 10 boxes of 50 Individual Swabsticks per case, REORDER NO. S40750, NDC 10819-4077-4; b) One Swabstick, 0.054 fl. Oz. (1.6 mL) Each in a pouch, 500 Individual Swabsticks per case, REORDER NO. S32450, NDC 10819-4077-2; c) One Swabstick, 0.054 fl. Oz. (1.6 mL) Each in a pouch, 500 Individual Swabsticks per case, REORDER NO. S42850, NDC 10819-4077-3; Professional Disposables International, Inc., Orangeburg, NY 10962-1376.; Lot #: a) 12000203, 12000204, Exp Mar 2022; 12001114 LE, Exp Jun 2022; 12001115 LE, 12001117 LE, Exp Jul 2022; 12001313, 12001407, 12001408, Exp Aug 2022; 12001498, 12001499, 12001500, 12001629, 12001630, Exp Sep 2022; 12002070, 12002114, Exp Dec 2022; 12100106, 12100107, 12100223, Exp Feb 2023; 12100224, 12100225, 12100354, 12100513, Exp Mar 2023; 12100514, 12100515, 12100605, 12100628, Exp Apr 2023; 12100629, 12100630, Exp May 2023; b) 12000332, Exp Feb 2022; 12000484, Exp Mar 2022; 12001116 LE, Exp Jul 2022; 12001312, Exp Aug 2022; 12001730, Exp Oct 2022; 12002071, 12100105, Exp Jan 2023; 12100222, Exp Mar 2023; 12100635, 12100636, Exp Jun 2023; c) 12000728, Exp Apr 2022; 12001119 LE, Exp Jul 2022; 12001631, Exp Oct 2022; 12001811, Exp Nov 2022; 12002115, 12002116, Exp Jan 2023; 12100221, Exp Feb 2023; 12100633, Exp May 2023; 12100634, 12100774, 12100817, Exp Jun 2023 | a) 28201 cases; b) 7579 cases; c) 8882 cases | 10819-4077-1, 10819-4077-4, 10819-4077-2, 10819-4077-3 |
What to do — step by step
Check Product Lot Number
Look for the lot number on the packaging, which is listed in the recall notice for specific dates from February 2022 through May 2023.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Product was distributed nationwide in the USA and Puerto Rico.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 21 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Similar recalls
Latest drug recalls
Keep exploring
Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0571-2022 (February 4, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0571-2022 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.