🔍 RecallPedia

PDI Povidone-Iodine Cleansing Scrub Swabstick (1's), 1 Swabstick, Professional Disposable International, Inc., Orangeburg, NY 10962 -1376 Reorder No S48050, NDC 10819-3891-2, UPC (01)00310819000192.

Class I - Dangerous
💊 Drugs Recalled: July 23, 2021 Professional Disposables International Other Drugs Nationwide

What Should You Do?

  1. Check if you have this product:
    Lot #'s 11901081, EXP 2023-04-04; 11901340, EXP 2023-04-05; 11901593, EXP 2023-04-06; 11901594, EXP 2023-04-07; 12000784, EXP 2023-04-08; 12000992, EXP 2023-04-09; 12001492, EXP 2023-04-10; 12001699, EXP 2023-04-11; 12100121, EXP 2023-04-12; 12100453, EXP 2023-04-13;
  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:
SubPotent: Out of Specification
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

PDI Povidone-Iodine Cleansing Scrub Swabstick (1's), 1 Swabstick, Professional Disposable International, Inc., Orangeburg, NY 10962 -1376 Reorder No S48050, NDC 10819-3891-2, UPC (01)00310819000192.

Product Codes/Lot Numbers:

Lot #'s 11901081, EXP 2023-04-04; 11901340, EXP 2023-04-05; 11901593, EXP 2023-04-06; 11901594, EXP 2023-04-07; 12000784, EXP 2023-04-08; 12000992, EXP 2023-04-09; 12001492, EXP 2023-04-10; 12001699, EXP 2023-04-11; 12100121, EXP 2023-04-12; 12100453, EXP 2023-04-13;

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-0762-2021

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Professional Disposables International

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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.

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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.

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 →