🔍 RecallPedia

PDI Povidone-Iodide Cleansing Scrub Swabstick (3's), 3 Swabsticks, Professional Disposable International, Inc., Orangeburg, NY 10962 -1376, Reorder No S82125, NDC 10819-3891-3, UPC (01)00310819000208.

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 11901080, EXP 2023-04-14; 11901339, EXP 2023-04-15; 11901755, EXP 2023-04-16; 12000016, EXP 2023-04-17; 12000397, EXP 2023-04-18; 12000987, EXP 2023-04-19; 12001578, EXP 2023-04-20; 12001814, EXP 2023-04-21;
  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-Iodide Cleansing Scrub Swabstick (3's), 3 Swabsticks, Professional Disposable International, Inc., Orangeburg, NY 10962 -1376, Reorder No S82125, NDC 10819-3891-3, UPC (01)00310819000208.

Product Codes/Lot Numbers:

Lot #'s 11901080, EXP 2023-04-14; 11901339, EXP 2023-04-15; 11901755, EXP 2023-04-16; 12000016, EXP 2023-04-17; 12000397, EXP 2023-04-18; 12000987, EXP 2023-04-19; 12001578, EXP 2023-04-20; 12001814, EXP 2023-04-21;

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-0763-2021

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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 →