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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Topical Products

Professional Disposables International, Inc: Povidone-Iodine Prep Pads and Swabsticks Recalled for Subpotency

Agency Publication Date: August 20, 2021
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Summary

Professional Disposables International (PDI) has voluntarily recalled 168,230 cases of various Povidone-Iodine Prep Pads and Cleansing Swabsticks. These medical products, used as topical antiseptics for skin preparation before surgery or injections, were found to be 'subpotent,' meaning the active ingredients do not meet the required concentration levels. This quality defect may reduce the effectiveness of the product in killing germs on the skin. Because these products are intended for professional and home healthcare use across the United States, consumers and medical staff should check their supplies for the specific lot numbers and expiration dates listed.

Risk

A subpotent antiseptic may fail to properly disinfect the skin, potentially increasing the risk of infection at the site of a medical procedure or injection. While no specific injuries have been reported, the reduced strength of the medication means it does not meet the necessary safety and performance specifications for its intended use.

What You Should Do

  1. Check your medical supplies for PDI Povidone-Iodine Prep Pads (Medium or Large), Swabsticks (1-count or 3-count), or Duo-Swab sets.
  2. Identify affected items by matching the lot numbers and expiration dates. For example, check for Prep Pad Medium lot 11800977 (Exp 2021-07-31) through 12100447 (Exp 2024-03-31), or Swabstick 1's lot 11900790 (Exp 2021-07-25) through 12100591 (Exp 2023-04-30).
  3. If you identify an affected product, stop using it immediately to ensure proper site disinfection.
  4. Contact your healthcare provider or pharmacist for guidance regarding alternative antiseptic products.
  5. Return any unused, recalled products to the place of purchase for a refund and contact Professional Disposables International, Inc. at their Woodcliff Lake, NJ location for further instructions.
  6. For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 or visit www.fda.gov/safety/recalls.

Your Remedy Options

💰Full Refund

Full refund for unused medication

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: PDI Povidone-Iodine Cleansing Scrub Swabstick (1's)
Model:
S48050
NDC 10819-3891-2
UPC Codes:
00310819000192
Lot Numbers:
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)
Product: PDI Povidone-Iodide Cleansing Scrub Swabstick (3's)
Model:
S82125
NDC 10819-3891-3
UPC Codes:
00310819000208
Lot Numbers:
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)
Product: PDI Duo-Swab Povidone-Iodine Cleansing Scrub Swabstick (1's)
Model:
S23125
NDC 10819-3891-1
NDC 10819-3890-1
UPC Codes:
00318019000161
Lot Numbers:
11900971
11901517
11901756
12000199
12000286
12000459
12000686
12000751
12001009
12001316
12001795
12001809
12001862
12001863
12002140
12002141
12100392
12100393
Product: PDI Povidone-Iodine Prep Pad MEDIUM
Model:
B40600
NDC 10819-3883-1
UPC Codes:
00310819000147
Lot Numbers (82):
11800977 (Exp 2021-07-31)
11800978 (Exp 2021-08-02)
11800979 (Exp 2021-08-04)
11801123 (Exp 2021-08-06)
11801124 (Exp 2021-08-09)
11801125 (Exp 2021-08-15)
11801126 (Exp 2021-08-16)
11801228 (Exp 2021-08-28)
11801230 (Exp 2021-09-11)
11801231 (Exp 2021-09-13)
11801232 (Exp 2021-09-18)
11801234 (Exp 2021-10-25)
11801417 (Exp 2021-10-28)
11801418 (Exp 2021-11-01)
11801419 (Exp 2021-11-07)
11801420 (Exp 2021-11-15)
11801421 (Exp 2021-11-20)
11801709 (Exp 2021-11-29)
11801710 (Exp 2021-12-04)
11900195 (Exp 2022-02-19)
11900196 (Exp 2022-02-21)
11900197 (Exp 2022-02-25)
11900370 (Exp 2022-04-01)
11900372 (Exp 2022-04-03)
11900371 (Exp 2022-04-05)
11900647 (Exp 2022-05-04)
11900623 (Exp 2022-05-21)
11900624 (Exp 2022-05-24)
11900646 (Exp 2022-05-29)
11900967 (Exp 2022-08-13)
11900968 (Exp 2022-08-26)
11900969 (Exp 2022-08-28)
11901043 (Exp 2022-09-11)
11901044 (Exp 2022-09-18)
11901318 (Exp 2022-10-03)
11901330 (Exp 2022-10-08)
11901331 (Exp 2022-10-16)
11901446 (Exp 2022-10-28)
11901447 (Exp 2022-11-19)
11901448 (Exp 2022-12-19)
11901739 (Exp 2023-01-02)
11901752 (Exp 2023-01-09)
12000045 (Exp 2023-01-14)
12000048 (Exp 2023-01-18)
12000046 (Exp 2023-01-21)
12000047 (Exp 2023-01-24)
12000333 (Exp 2023-01-25)
12000675 (Exp 2023-02-16)
12000334 (Exp 2023-02-27)
12000335 (Exp 2023-02-27)
Product: PDI Povidone-Iodine Prep Pad Large
Model:
C12400
NDC 10819-3883-3
UPC Codes:
00310819000154
Lot Numbers:
11801215 (EXP 2021-08-22)
11801504 (EXP 2021-11-06)
11801717 (EXP 2021-12-07)
11900421 (EXP 2022-04-04)
11901076 (EXP 2022-08-29)
11901571 (EXP 2022-11-19)
12000388 (EXP 2023-03-13)
12001533 (EXP 2023-07-28)
12100459 (EXP 2024-03-31)
Product: PDI Povidine Iodine Swabstick (1's)
Model:
S41350
NDC 10819-3885-1
UPC Codes:
00310819000178
Lot Numbers (66):
11900790 (EXP 2021-07-25)
11900919 (EXP 2021-07-28)
11900920 (EXP 2021-08-12)
11900921 (EXP 2021-08-15)
11901106 (EXP 2021-08-27)
11901107 (EXP 2021-08-30)
11901128 (EXP 2021-09-05)
11901129 (EXP 2021-09-12)
11901249 (EXP 2021-09-25)
11901250 (EXP 2021-10-17)
11901391 (EXP 2021-10-19)
11901392 (EXP 2021-10-22)
11901438 (EXP 2021-10-24)
11901439 (EXP 2021-10-08)
11901457 (EXP 2021-11-07)
11901541 (EXP 2021-11-18)
11901603 (EXP 2021-11-19)
11901604 (EXP 2021-12-19)
11901669 (EXP 2021-12-19)
11901670 (EXP 2021-11-16)
11901702 (EXP 2021-12-02)
11901703 (EXP 2021-12-14)
12000082 (EXP 2021-12-19)
12000083 (EXP 2022-01-24)
12000118 (EXP 2022-01-03)
12000119 (EXP 2022-01-30)
12000249 (EXP 2022-01-10)
12000250 (EXP 2022-01-10)
12000348 (EXP 2022-02-13)
12000349 (EXP 2022-02-28)
12000398 (EXP 2022-02-05)
12000456 (EXP 2022-03-12)
12000457 (EXP 2022-03-12)
12000683 (EXP 2022-03-23)
12000684 (EXP 2022-03-30)
12000685 (EXP 2022-04-04)
12000922 (EXP 2022-05-15)
12000923 (EXP 2022-05-19)
12000927 (EXP 2022-05-21)
12000989 (EXP 2022-06-15)
12000990 (EXP 2022-06-05)
12000991 (EXP 2022-06-10)
12001154 (EXP 2022-06-26)
12001155 (EXP 2022-06-24)
12001231 (EXP 2022-07-26)
12001232 (EXP 2022-07-21)
12001243 (EXP 2022-07-03)
12001244 (EXP 2022-07-04)
12001537 (EXP 2022-08-31)
12001538 (EXP 2022-08-31)
Product: PDI Povidone-Iodine Swabstick (3's)
Model:
S41125
NDC 10819-3885-2
UPC Codes:
00310819000185
Lot Numbers (86):
11900761 (EXP 2022-11-03)
11900917 (EXP 2022-11-04)
11900918 (EXP 2022-11-05)
11901008 (EXP 2022-11-06)
11901009 (EXP 2022-11-07)
11901124 (EXP 2022-11-08)
11901125 (EXP 2022-11-09)
11901126 (EXP 2022-11-10)
11901127 (EXP 2022-11-11)
11901179 (EXP 2022-11-12)
11901180 (EXP 2022-11-13)
11901247 (EXP 2022-11-14)
11901248 (EXP 2022-11-15)
11901388 (EXP 2022-11-16)
11901389 (EXP 2022-11-17)
11901390 (EXP 2022-11-18)
11901419 (EXP 2022-11-19)
11901420 (EXP 2022-11-20)
11901480 (EXP 2022-11-21)
11901558 (EXP 2022-11-22)
11901590 (EXP 2022-11-23)
11901591 (EXP 2022-11-24)
11901592 (EXP 2022-11-25)
11901691 (EXP 2022-11-26)
11901692 (EXP 2022-11-27)
12000054 (EXP 2022-11-28)
12000055 (EXP 2022-11-29)
12000116 (EXP 2022-11-30)
12000117 (EXP 2022-12-01)
12000172 (EXP 2022-12-02)
12000173 (EXP 2022-12-03)
12000189 (EXP 2022-12-04)
12000190 (EXP 2022-12-05)
12000287 (EXP 2022-12-06)
12000288 (EXP 2022-12-07)
12000346 (EXP 2022-12-08)
12000347 (EXP 2022-12-09)
12000452 (EXP 2022-12-10)
12000453 (EXP 2022-12-11)
12000454 (EXP 2022-12-12)
12000455 (EXP 2022-12-13)
12000679 (EXP 2022-12-14)
12000680 (EXP 2022-12-15)
12000681 (EXP 2022-12-16)
12000682 (EXP 2022-12-17)
12000881 (EXP 2022-12-18)
12000882 (EXP 2022-12-19)
12000883 (EXP 2022-12-20)
12000884 (EXP 2022-12-21)
12001003 (EXP 2022-12-22)

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 88326
Status: Resolved
Manufacturer: Professional Disposables International, Inc
Sold By: professional healthcare providers; hospitals; pharmacies
Manufactured In: United States
Units Affected: 7 products (53588 cases; 1982 cases; 41,105 cases; 51,926 cases; 5,477 cases; 3,113 cases; 11,039 cases)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.