CLASS II Drug recall · Reported 2 Mar 2022 · FDA Enforcement Report
Prevantics (chlorhexidine gluconate recalled by Professional Disposables
Professional Disposables International is recalling Prevantics (chlorhexidine gluconate and isopropyl alcohol) Swab, 3.15% w/v and 70% v/v, distributed nationwide in the US. The recall was initiated on 4 Feb 2022 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0571-2022
- FDA event ID
- 89547
- Recalling firm
- Professional Disposables International, Orangeburg, NY
- Brand
- Prevantics Swab
- Manufacturer
- Professional Disposables International, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 4 Feb 2022
- FDA classified
- 18 Feb 2022
- Reported
- 2 Mar 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
Timeline
| 4 Feb 2022 | Recall initiated by company | |
| 18 Feb 2022 | Classified by FDA | +14 days |
| 2 Mar 2022 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
cGMP deviations: uncertainty of the adequacy of the validation of the test methods used to manufacture the products.
Product as listed by the FDA
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.
Where it was distributed
Product was distributed nationwide in the USA and Puerto Rico.
Questions about this recall
Why was it recalled?
cGMP deviations: uncertainty of the adequacy of the validation of the test methods used to manufacture the products.
Which lots are affected?
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
Where was it sold?
Product was distributed nationwide in the USA and Puerto Rico.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 89547| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Prevantics (chlorhexidine gluconate recalled by Professional DisposablesPrevantics Maxi Swabstick | Professional Disposables International | Manufacturing (CGMP) Deviations | Nationwide | |
| CLASS II | Prevantics (chlorhexidine gluconate recalled by Professional DisposablesPrevantics Swabstick | Professional Disposables International | Manufacturing (CGMP) Deviations | Nationwide |
More recalls from Professional Disposables International
All 10| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Prevantics (chlorhexidine gluconate recalled by Professional DisposablesPrevantics Swabstick | Professional Disposables International | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Prevantics (chlorhexidine gluconate recalled by Professional DisposablesPrevantics Maxi Swabstick | Professional Disposables International | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | PDI Povidine Iodine Swabstick (1's), 1 swabstick recalledPvp Iodine Prep Pad | Professional Disposables International | Potency & Assay | Nationwide |
| Drug | CLASS II | PDI Povidone-Iodide Cleansing Scrub Swabstick (3's) recalled | Professional Disposables International | Potency & Assay | Nationwide |
| Drug | CLASS II | PDI Povidone-Iodine Prep Pad Medium, 1 Prep Pad [] recalledPvp Iodine Prep Pad | Professional Disposables International | Potency & Assay | Nationwide |
Other Chlorhexidine Gluconate recalls
All 35| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | 2% Chlorhexidine Gluconate* Cloth, Non-sterile recalled by Sage ProductsChlorhexidine Gluconate | Sage Products | Other | Nationwide |
| Drug | CLASS II | BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate recalledChloraprep One-step | CareFusion 213 | Sterility | Nationwide |
| Drug | CLASS II | BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) recalledChloraprep One-step | CareFusion 213 | Sterility | Nationwide |
| Drug | CLASS II | BD ChloraPrep Hi-Lite Orange recalled by CareFusion 213Chloraprep One-step | CareFusion 213 | Sterility | Nationwide |
| Drug | CLASS II | BD ChloraPrep Scrub Teal, (2% w/v chlorhexidine gluconate recalledChloraprep One-step | CareFusion 213 | Sterility | Nationwide |