Pacific Disposables International has announced a voluntary recall of its non-sterile alcohol prep pads.
The announcement comes as a precaution to emerging concerns posed by the U.S. Food and Drug Administration regarding the presence of B. cereus in non-sterile alcohol prep pads. PDI's recall mirrors similar quality-related concerns associated with H&P Industries and Triad Group, which distribute and manufacture a variety of over-the-counter drug products including povidone-iodine and benzalkonium chloride antiseptic products.
Recently, H&P and Triad Group has come under fire from federal officials for failing to comply with regulatory quality standards.
Since Dec. 2010, H&P Industries issued five voluntary product recalls due to bacterial contamination found in its products, including medical wipes and pads. The FDA also discovered H&P committed other violations, including continuing problems with an air handling system, failure to adequately investigate drug products that did not meet specifications and failure to take appropriate measures to ensure the quality of incoming components.
In April, U.S. Marshals seized more than $6 million in products held at the Triad Group and H&P Industries Hartland facility. Then in June, the FDA filed a consent decree of condemnation, forfeiture, and permanent injunction against H&P Industries, Triad Group and three individuals that will prevent them from manufacturing and distributing products from any facility.
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The announcement comes as a precaution to emerging concerns posed by the U.S. Food and Drug Administration regarding the presence of B. cereus in non-sterile alcohol prep pads. PDI's recall mirrors similar quality-related concerns associated with H&P Industries and Triad Group, which distribute and manufacture a variety of over-the-counter drug products including povidone-iodine and benzalkonium chloride antiseptic products.
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Recently, H&P and Triad Group has come under fire from federal officials for failing to comply with regulatory quality standards.
Since Dec. 2010, H&P Industries issued five voluntary product recalls due to bacterial contamination found in its products, including medical wipes and pads. The FDA also discovered H&P committed other violations, including continuing problems with an air handling system, failure to adequately investigate drug products that did not meet specifications and failure to take appropriate measures to ensure the quality of incoming components.
In April, U.S. Marshals seized more than $6 million in products held at the Triad Group and H&P Industries Hartland facility. Then in June, the FDA filed a consent decree of condemnation, forfeiture, and permanent injunction against H&P Industries, Triad Group and three individuals that will prevent them from manufacturing and distributing products from any facility.
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