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povidone iodine FDA Alerts

The FDA Alert(s) below may be specifically about povidone iodine or relate to a group or class of drugs which include povidone iodine.

MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings. For the latest FDA MedWatch alerts, go here.

Recent FDA Alert(s) for povidone iodine

H & P Industries Povidone Iodine Swabsticks, Prep Solutions, Scrub Solutions, and Prep Gel: Recall - Inadequate Microbial Testing

Sep 25, 2012

Audience: Pharmacy, Consumer, Risk Manager

Multiple brands affected - listed below

[UPDATED 09/18/2012] Custom Medical Specialties, Inc., Custom HSG Tray, Hysteroscopic Sterilization Pack, Custom Vein Tray, Custom Amnio Tray, Fox Chase Specials Pack, Abington Radiology Drainage Pack, Custom CT Biopsy Tray, HSG Tray, Custom Myelogram Tray, and Hysteroscopy Sterile Procedure Kit. Class 1 Recall. The custom surgical kits contain Povidone Iodine Prep solution that had previously been recalled by H & P Industries, Inc. The manufacturer did not conduct any microbial testing and the products did not meet proper finished specifications. These products may cause serious adverse health consequences, including death. See the Recall Notice for a listing of affected brand names and lot numbers.

 

[Posted 08/27/2011]

ISSUE: H & P Industries and FDA notified health professionals and the public of a recall of all lots (lots beginning with 8J-8M, 9A-9M, 0A-0M, 1A-1C) of Povidone Iodine Swabsticks, Prep Solutions, Scrub Solutions, and Prep Gel. H & P Industries, Inc. manufactured these Povidone Iodine products without having in place a system for microbial testing at the time of release, without having a system for testing of incoming components, and without having procedures designed and established to prevent objectionable microorganisms in these drug products. Patients undergoing medical and surgical procedures, including those who are immunocompromised, have a high risk of infection from antiseptic surgical preparations that have been prepared, packaged, or held under insanitary conditions. This recall has been initiated at the request of FDA.

BACKGROUND: Povidone Iodine Swabsticks, Povidone Iodine Prep Solutions, Povidone Iodine Scrub Solutions, and Povidone Iodine Prep Gel are labeled as an antiseptic for preparation of the skin prior to surgery, and are used to prevent infection in minor cuts, scrapes and burns. The Povidone Iodine Scrub solutions are labeled also for use as a surgical hand scrub for health care professionals. The Povidone Iodine products were distributed nationwide to healthcare customers. The swabsticks are packaged in individual packets of 1 or 3 swabs and the Prep Solution, Scrub Solution and Prep Gel are sold in bottles.

RECOMMENDATION: Specific customers distributing the product and selling it at the wholesale and hospital level are being notified by e-mail with instructions on how to return the product. Consumers that have any of these types of products in their possession should not use the product and should return it to the place it was purchased.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

H & P Industries Povidone Iodine Prep Pads: Recall - Potential Microbial Contamination

Feb 8, 2012

Audience: Pharmacy, Consumer, Risk Manager

Including products under brand names Cardinal Health, Medical Specialties, VHA, Triad, Triad Plus, North Safety, Total Resources, Atwater Carey, Lee Medical International, NAR Surgical

 

[UPDATED 02/08/2012] NAR Surgical Crichothyroidotomy Kit or Crickit kits recalled. See the Recall Notice for a listing of affected brand names and lot numbers.

[UPDATED 10/03/2011] Additional Lee Medical International Inc., Custom Dialysis Trays/Kits recalled. See the Recall Notice for a listing of affected brand names and lot numbers.

[UPDATED 09/16/2011] Lee Medical International Inc., Custom Dialysis Trays/Kits recalled. See the Recall Notice for a listing of affected brand names and lot numbers.

[UPDATED 05/03/2011] Consumers using one of the affected First Aid Kits should immediately dispose of the Triad Povidone Iodine Prep Pads included in the First Aid Kits.
 

[Posted 03/18/2011]

ISSUE: H&P industries, Inc., a manufacturer of over-the-counter products, initiated a voluntary product recall of ALL LOTS of Povidone Prep Pads manufactured by H&P Industries, Inc. but which are private labeled for many accounts. Analytical testing showed the presence of Elizabethkingia meningoseptica. Use of contaminated Povidone Prep Pads could lead to life-threatening infections, especially in at risk populations, including neonates, immune suppressed patients, and surgical patients. Treatment options are limited for Elizabethkingia meningoseptica infections.

BACKGROUND: Povidone Iodine Prep Pads are used to prevent infection in minor cuts, scrapes and burns and are labeled as an antiseptic for preparation of the skin prior to surgery. They were distributed nationwide to healthcare customers and are packaged in individual packets and sold in a box of 100 packets.

RECOMMENDATION: Healthcare organizations should contact H&P Industries Customer Service to arrange a return. If a consumer has any of these types of products in their possession, they should not use the product.

 

Healthcare professionals and patients are encouraged to report adverse events, side effects, or product quality problems related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

H & P Industries Povidone Iodine Prep Pads: Recall - Potential Microbial Contamination

Oct 3, 2011

Audience: Pharmacy, Consumer, Risk Manager

Including products under brand names Cardinal Health, Medical Specialties, VHA, Triad, Triad Plus, North Safety, Total Resources, Atwater Carey, Lee Medical International

 

[UPDATED 10/03/2011] Additional Lee Medical International Inc., Custom Dialysis Trays/Kits recalled. See the Recall Notice for a listing of affected brand names and lot numbers.

[UPDATED 09/16/2011] Lee Medical International Inc., Custom Dialysis Trays/Kits recalled. See the Recall Notice for a listing of affected brand names and lot numbers.

[UPDATED 05/03/2011] Consumers using one of the affected First Aid Kits should immediately dispose of the Triad Povidone Iodine Prep Pads included in the First Aid Kits.
 

[Posted 03/18/2011]

ISSUE: H&P industries, Inc., a manufacturer of over-the-counter products, initiated a voluntary product recall of ALL LOTS of Povidone Prep Pads manufactured by H&P Industries, Inc. but which are private labeled for many accounts. Analytical testing showed the presence of Elizabethkingia meningoseptica. Use of contaminated Povidone Prep Pads could lead to life-threatening infections, especially in at risk populations, including neonates, immune suppressed patients, and surgical patients. Treatment options are limited for Elizabethkingia meningoseptica infections.

BACKGROUND: Povidone Iodine Prep Pads are used to prevent infection in minor cuts, scrapes and burns and are labeled as an antiseptic for preparation of the skin prior to surgery. They were distributed nationwide to healthcare customers and are packaged in individual packets and sold in a box of 100 packets.

RECOMMENDATION: Healthcare organizations should contact H&P Industries Customer Service to arrange a return. If a consumer has any of these types of products in their possession, they should not use the product.

 

Healthcare professionals and patients are encouraged to report adverse events, side effects, or product quality problems related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

H & P Industries Povidone Iodine Prep Pads: Recall - Potential Microbial Contamination

Sep 16, 2011

Audience: Pharmacy, Consumer, Risk Manager

Including products under brand names Cardinal Health, Medical Specialties, VHA, Triad, Triad Plus, North Safety, Total Resources, Atwater Carey, Lee Medical International

[UPDATED 09/16/2011] Lee Medical International Inc., Custom Dialysis Trays/Kits recalled. See the Recall Notice for a listing of affected brand names and lot numbers.

[UPDATED 05/03/2011] Consumers using one of the affected First Aid Kits should immediately dispose of the Triad Povidone Iodine Prep Pads included in the First Aid Kits.
 

[Posted 03/18/2011]

ISSUE: H&P industries, Inc., a manufacturer of over-the-counter products, initiated a voluntary product recall of ALL LOTS of Povidone Prep Pads manufactured by H&P Industries, Inc. but which are private labeled for many accounts. Analytical testing showed the presence of Elizabethkingia meningoseptica. Use of contaminated Povidone Prep Pads could lead to life-threatening infections, especially in at risk populations, including neonates, immune suppressed patients, and surgical patients. Treatment options are limited for Elizabethkingia meningoseptica infections.

BACKGROUND: Povidone Iodine Prep Pads are used to prevent infection in minor cuts, scrapes and burns and are labeled as an antiseptic for preparation of the skin prior to surgery. They were distributed nationwide to healthcare customers and are packaged in individual packets and sold in a box of 100 packets.

RECOMMENDATION: Healthcare organizations should contact H&P Industries Customer Service to arrange a return. If a consumer has any of these types of products in their possession, they should not use the product.

 

Healthcare professionals and patients are encouraged to report adverse events, side effects, or product quality problems related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

H & P Industries Povidone Iodine Swabsticks, Prep Solutions, Scrub Solutions, and Prep Gel: Recall - Inadequate Microbial Testing

Aug 26, 2011

Audience: Pharmacy, Consumer, Risk Manager

ISSUE: H & P Industries and FDA notified health professionals and the public of a recall of all lots (lots beginning with 8J-8M, 9A-9M, 0A-0M, 1A-1C) of Povidone Iodine Swabsticks, Prep Solutions, Scrub Solutions, and Prep Gel. H & P Industries, Inc. manufactured these Povidone Iodine products without having in place a system for microbial testing at the time of release, without having a system for testing of incoming components, and without having procedures designed and established to prevent objectionable microorganisms in these drug products. Patients undergoing medical and surgical procedures, including those who are immunocompromised, have a high risk of infection from antiseptic surgical preparations that have been prepared, packaged, or held under insanitary conditions. This recall has been initiated at the request of FDA.

BACKGROUND: Povidone Iodine Swabsticks, Povidone Iodine Prep Solutions, Povidone Iodine Scrub Solutions, and Povidone Iodine Prep Gel are labeled as an antiseptic for preparation of the skin prior to surgery, and are used to prevent infection in minor cuts, scrapes and burns. The Povidone Iodine Scrub solutions are labeled also for use as a surgical hand scrub for health care professionals. The Povidone Iodine products were distributed nationwide to healthcare customers. The swabsticks are packaged in individual packets of 1 or 3 swabs and the Prep Solution, Scrub Solution and Prep Gel are sold in bottles.

RECOMMENDATION: Specific customers distributing the product and selling it at the wholesale and hospital level are being notified by e-mail with instructions on how to return the product. Consumers that have any of these types of products in their possession should not use the product and should return it to the place it was purchased.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:


[08/24/2011 - Press Release - H&P Industries, Inc]


Swabsticks
Amerinet
Cardinal Health
Nova Plus
PSS Select
Triad
Triad Plus
 
Prep Solutions
American Fare
Amerinet
Equaline
Fred's
Good Neighbor
Good Sense
Laura Lynn
Leader
Major
Meijer
Nova Plus
Premiere Value
PSS Select
Triad
Triad Plus
Walgreens
Winn Dixie
 
Gel
Triad Plus
 
Scrub
Amerinet
Nova Plus
Triad
Triad Plus

H & P Industries Povidine Iodine Prep Pads: Recall - Potential Microbial Contamination

Mar 18, 2011

Audience: Pharmacy, Consumer, Risk Manager

Including products under brand names Cardinal Health, Medical Specialties, VHA, Triad, Triad Plus, North Safety, Total Resources

[Posted 03/18/2011]

ISSUE: H&P industries, Inc., a manufacturer of over-the-counter products, initiated a voluntary product recall of ALL LOTS of Povidine Prep Pads manufactured by H&P Industries, Inc. but which are private labeled for many accounts. Analytical testing showed the presence of Elizabethkingia meningoseptica. Use of contaminated Povidine Prep Pads could lead to life-threatening infections, especially in at risk populations, including neonates, immune suppressed patients, and surgical patients. Treatment options are limited for Elizabethkingia meningoseptica infections.

BACKGROUND: Povidine Iodine Prep Pads are used to prevent infection in minor cuts, scrapes and burns and are labeled as an antiseptic for preparation of the skin prior to surgery. They were distributed nationwide to healthcare customers and are packaged in individual packets and sold in a box of 100 packets.

RECOMMENDATION: Healthcare organizations should contact H&P Industries Customer Service to arrange a return. If a consumer has any of these types of products in their possession, they should not use the product.

 

Healthcare professionals and patients are encouraged to report adverse events, side effects, or product quality problems related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

 

[03/15/2011 - Press Release - H&P Industries, Inc.]

    

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