Triad Sterile Wipes Recall

Serious Infections could have been caused by contaminated Triad Alcohol Wipes, Medical Pad, and other products

On January 3, 2011 The Triad Group issued recall of all lots of alcohol prep pads, alcohol swabs, and alcohol swabsticks after receiving complaints of potential contamination with an objectionable organism, Bacillus cereus. The recall came only after a 2-year-old toddler had died in December last after being infected with the Bacillus cereus, which resulted in multi-organ failure.

Triad’s recall covers all lots of its alcohol prep pads, wipes and swabs, totaling perhaps hundreds of millions of products sold in the U.S., Canada and Europe.

H&P Industries, which does business as the Triad Group, is among the largest providers in the U.S. of generic medical products often sold under private labels of grocery stores such as Safeway and Kroger and drugstores such as CVS and Walgreens.

Previously, Triad has also recalled sterile lubricating jelly after several cases of vaginal infection in women were reported. Before that recall, from July 2009 to May 2010, Triad received six complaints from hospitals about high rates of abnormal pap smear cases related to its understerilized lubricating jelly; however, it failed to evaluate and investigate these complaints or even address the previously detected high microbial burden levels in the jelly. FDA inspection reports found that the Triad Group released products for distribution despite the failure of another batch of the same product to meet quality standards.

Food and Drug Administration inspectors knew about problems with contamination and sterilization at a plant run by the Triad Group of Hartland, Wis., as early as July 2009.

FDA officials expressed concerns following visits to the Triad plant from July 15 to July 17, 2009, and again from April 19 to May 18, 2010. FDA Inspectors reported that the company could not validate the processes used to ensure quality or sterility not only of alcohol prep pads and wipes, but also other products used for intimate care, including hemorrhoid creams, infant and adult glycerin suppositories and sterile lubricating jelly widely used in homes, as well as in clinics and hospitals for medical exams.

FDA inspectors cited Triad’s sterilization process for alcohol prep products, questioning dosages of the gamma radiation process that ensures sterility. “Specifically, there is no validation of the gamma radiation sterilization process for the Alcohol Swabsticks labeled as sterile.”

In addition, shipments of Triad Plus BZK prep pads that failed to meet specifications were released for distribution, FDA inspectors said. FDA Inspectors also reported worn and broken manufacturing equipment, misidentified batches of hemorrhoid cream, and instances where if a single batch of hemorrhoid ointment or glycerin suppositories failed quality standards, others weren’t tested for the same problem and were released for distribution.

In one case, inspectors noted that a batch of lubricating jelly failed viscosity tests on Jan. 28, 2010, but was released anyway with the specific consent of Triad’s president, David Haertle. A week later, the decision to release the jelly per Haertle’s authority was revised and cases of the jelly were scrapped, but some already had been distributed. “No action was taken on the distributed cases,” inspectors wrote.

Over 100 reports of problems with alcohol prep pads were logged by the FDA since the Jan. 5, 2011 recall of Triad products because of potential contamination with the bacteria Bacillus cereus.

Finally, on April 6, 2011 Federal marshals seized more than $6 million in over-the-counter drug products at the Wisconsin facility owned by Triad Group Inc. because of manufacturing violations. The seizure was ordered by the FDA after H&P Industries Inc., which shares an owner with Triad Group, failed to comply with good manufacturing practice regulations, according to the agency. The FDA said the products seized at the Hartland, Wis., facility included povidone-iodine and benzalkonium chloride antiseptic products, cough and cold remedies, nasal sprays, suppositories, medicated wipes, antifungal creams, hemorrhoidal wipes, in-process drug products, and raw materials.

The Triad products have resulted in different types of injuries, including superficial skin infections, serious complications, endomyocarditis, and even permanent disability.

If you or someone you love has suffered from a severe infection or other injuries after using any contaminated Triad products, in a hospital or at home, contact the Plymale Law Firm for a free consultation by filling out the form on this page or by calling us at (877) 328-767­­0.

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