Download INFORMATIONAL ALERT August 29, 2011

INFORMATIONAL ALERT
August 29, 2011
TO:
Eye Banks, Executive Directors and Medical Directors
FROM:
Jennifer DeMatteo, EBAA Director of Regulations and Standards
SUBJECT:
Recall of H&P Industries Povidone Iodine Swabsticks, Prep Solutions, Scrub
Solutions and Prep Gel
All lots (beginning with 8J-8M, 9A-9M, 0A-0M, 1A-1C) of Povidone Iodine Swabsticks, Prep Solutions,
Scrub Solutions, and Prep Gel manufactured by H & P Industries (Hartland, Wisconsin) have been
recalled at the request of the FDA. 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.
These products were distributed nationwide to healthcare consumers. 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.
See the list below for the various distributors of the affected Povidone Iodine products.
You should not use the affected products and should return it to the place it was purchased for a full
refund. Consumers with questions can call H&P Industries, Inc. at 262-538-2907 Monday through Friday
between the hours of 8:30 A.M. and 4:00 P.M. Central Time. 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.
The link to the MedWatch Safety Alert is below:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm
269800.htm
Swabsticks
Amerinet
Cardinal Health
Nova Plus
PSS Select - Select Medical Products
Triad
Triad Plus
Prep Solutions
American Fare - Smart Sense, Kmart
Amerinet
Equaline, Albertson's
Fred's
Good Neighbor - Good Neighbor Pharmacy, Amerisource Bergen
Good Sense - Geiss, Destin & Dunn, Inc.
Leader - Cardinal Health
Major
Meijer
Nova Plus
Premiere Value - Chain Drug Consortium
PSS Select - Select Medical Products. PSS World Medical
Triad - Triadine
Triad Plus
Walgreens
Winn Dixie - Medic
Gel
Triad Plus
Scrub
Amerinet
Nova Plus
Triad
Triad Plus