FYI... FDA MedWatch - H&P Industries Povidine Iodine Prep Pads: Recall - Potential Microbial Contamination

[Guest guest]

H & P Industries Povidine Iodine Prep Pads

Including products under brand names Cardinal Health, Medical Specialties, VHA,

Triad, Triad Plus, North Safety, Total Resources

AUDIENCE: Pharmacy, Consumer, Risk Manager

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 kingia

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 kingia 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:

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm

Download form or call 1-800-332-1088 to request a reporting form, then complete

and return to the address on the pre-addressed form, or submit by fax to

1-800-FDA-0178

Read the MedWatch safety alert, including a link to the Press Release, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedical\

Products/ucm247743.htm

Tell us how we are doing:

http://survey.foreseeresults.com/survey/display?cid=d509U9xg0gZVxkMRcoMsQg== & sid\

=link & cpp[date]=03_21_2011_1423 & cpp[type]=S

You are encouraged to report all serious adverse events and product quality

problems to FDA MedWatch at www.fda.gov/medwatch/report.htm

Follow MedWatch on Twitter

This service is provided to you at no charge by U.S. Food & Drug Administration

(FDA).

U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring,

MD 20993 · 800-439-1420

[Guest guest]

H & P Industries Povidine Iodine Prep Pads

Including products under brand names Cardinal Health, Medical Specialties, VHA,

Triad, Triad Plus, North Safety, Total Resources

AUDIENCE: Pharmacy, Consumer, Risk Manager

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 kingia

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 kingia 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:

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm

Download form or call 1-800-332-1088 to request a reporting form, then complete

and return to the address on the pre-addressed form, or submit by fax to

1-800-FDA-0178

Read the MedWatch safety alert, including a link to the Press Release, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedical\

Products/ucm247743.htm

Tell us how we are doing:

http://survey.foreseeresults.com/survey/display?cid=d509U9xg0gZVxkMRcoMsQg== & sid\

=link & cpp[date]=03_21_2011_1423 & cpp[type]=S

You are encouraged to report all serious adverse events and product quality

problems to FDA MedWatch at www.fda.gov/medwatch/report.htm

Follow MedWatch on Twitter

This service is provided to you at no charge by U.S. Food & Drug Administration

(FDA).

U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring,

MD 20993 · 800-439-1420

[Guest guest]

H & P Industries Povidine Iodine Prep Pads

Including products under brand names Cardinal Health, Medical Specialties, VHA,

Triad, Triad Plus, North Safety, Total Resources

AUDIENCE: Pharmacy, Consumer, Risk Manager

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 kingia

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 kingia 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:

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm

Download form or call 1-800-332-1088 to request a reporting form, then complete

and return to the address on the pre-addressed form, or submit by fax to

1-800-FDA-0178

Read the MedWatch safety alert, including a link to the Press Release, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedical\

Products/ucm247743.htm

Tell us how we are doing:

http://survey.foreseeresults.com/survey/display?cid=d509U9xg0gZVxkMRcoMsQg== & sid\

=link & cpp[date]=03_21_2011_1423 & cpp[type]=S

You are encouraged to report all serious adverse events and product quality

problems to FDA MedWatch at www.fda.gov/medwatch/report.htm

Follow MedWatch on Twitter

This service is provided to you at no charge by U.S. Food & Drug Administration

(FDA).

U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring,

MD 20993 · 800-439-1420

[Guest guest]

H & P Industries Povidine Iodine Prep Pads

Including products under brand names Cardinal Health, Medical Specialties, VHA,

Triad, Triad Plus, North Safety, Total Resources

AUDIENCE: Pharmacy, Consumer, Risk Manager

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 kingia

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 kingia 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:

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm

Download form or call 1-800-332-1088 to request a reporting form, then complete

and return to the address on the pre-addressed form, or submit by fax to

1-800-FDA-0178

Read the MedWatch safety alert, including a link to the Press Release, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedical\

Products/ucm247743.htm

Tell us how we are doing:

http://survey.foreseeresults.com/survey/display?cid=d509U9xg0gZVxkMRcoMsQg== & sid\

=link & cpp[date]=03_21_2011_1423 & cpp[type]=S

You are encouraged to report all serious adverse events and product quality

problems to FDA MedWatch at www.fda.gov/medwatch/report.htm

Follow MedWatch on Twitter

This service is provided to you at no charge by U.S. Food & Drug Administration

(FDA).

U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring,

MD 20993 · 800-439-1420