🔍 RecallPedia

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.

Class I - Dangerous
💊 Drugs Recalled: February 4, 2022 Professional Disposables International Other Drugs Nationwide

What Should You Do?

  1. Check if you have this product:
    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
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. 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) 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.

Product Codes/Lot Numbers:

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

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-0572-2022

Related Recalls

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.

Professional Disposables International

Class I - Dangerous

cGMP deviations: uncertainty of the adequacy of the validation of the test methods used to manufacture the products.

Feb 4, 2022 Other Drugs Nationwide View Details →

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.

Professional Disposables International

Class I - Dangerous

cGMP deviations: uncertainty of the adequacy of the validation of the test methods used to manufacture the products.

Feb 4, 2022 Other Drugs Nationwide View Details →