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:

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