Voluntary Product Recall of PDI® Non-sterile Alcohol Prep Pads
Recall effective September 20, 2011
PDI has decided to voluntarily recall its non-sterile alcohol
prep pads as a precaution to emerging concerns posed by the
FDA regarding the presence of B. cereus in non-sterile alcohol
prep pads. Please note that this recall affects ONLY non-sterile alcohol
prep pads. PDI products are manufactured under cGMPs (current Good Manufacturing
Practices), are compliant with United States Pharmacopeia (USP) standards and are
tested prior to shipping. Again, this recall is precautionary and voluntary.
To facilitate response to any questions customers, patients or healthcare professionals
may have regarding this voluntary recall, we have activated this website and a customer
support line along with our product support email address. The dedicated customer
support team can be reached at 800.999.6423 x8240. Emails should be sent to productsupport@pdipdi.com.
To ensure we continue to provide safe and efficacious products that meet and exceed
FDA requirements, PDI has updated our product specifications to ensure the absence
of B. cereus in our non-sterile alcohol prep pads. In addition, PDI has always and
will continue to conduct pre-shipping testing of all non-sterile alcohol prep pads
products manufactured under Good Manufacturing Practices, and only ship those products
that meet our high quality standards.
As you may know, all of us at PDI -- who invented the category of alcohol prep pads
-- are deeply committed to continuing to provide safe and efficacious products.
PDI has and will continue to work with FDA to ensure our products meet or exceed
FDA requirements.
Instructions
PDI, Inc. has decided to conduct a voluntary product recall of PDI®
Non-sterile Alcohol Prep Pads including item numbers:
| Item # | Product Description | Packing |
| B33901 | PDI Alcohol Prep Pads non sterile - Med | 10/200's |
| B33905 | PDI Alcohol Prep Pads non sterile - Med | 15/200's |
| B33973 | PDI Alcohol Prep Pads non sterile - Med | 3000 |
| B68870 | PDI Alcohol Prep Pads non sterile - Med | 12/100's |
| C29600 | PDI Alcohol Prep Pads non sterile - Lge | 10/100's |
| B34700 | Proadvantage Alcohol Prep Pads non-sterile | 10/200's |
| C36100 | Proadvantage Alcohol Prep Pads Large | 10/100's |
| B85637 | Medi-Pak Alcohol Prep Pads non sterile-Med | 15/200's |
| C42500 | Medi-Pak Alcohol Prep Pads non sterile-Lge | 10/100's |
| B91437 | Medi-Choice Alcohol Prep Pads non sterile- Med | 15/200's |
| C73400 | Medi-Choice Alcohol Prep Pads non sterile- Large | 10/100's |
| B32071 | ShopRite Alcohol Prep Pads non sterile - Medium | 12/100's |
| B81071 | Duane Reade Alcohol Prep Pads non sterile - Medium | 12/100's |
This recall is for lots of the above mentioned products still within product expiration date.
Affected Products
Please type the Lot Number located on your product packaging in the box below to check if it's affected.
For frequently asked questions, click here.
For additional information please email productsupport@pdipdi.com or call 800-444-6725.
For Return Authorization information, please download the Recall Response Form (PDF).
You can find the Lot Number on the inside of the box cover or on the individual package. The Lot Numbers are circled in the sample images below.
Inside of the Box Cover
Individual Package
