Contaminated Alcohol Wipes May Be Sign of Larger Triad Products Problem

The recall of tens of millions of contaminated alcohol wipes by the Triad Group last month may just be the tip of the iceberg, as FDA inspections and reports appear to indicate systemic sterility problems with the company’s products. 

A Triad alcohol swabs and prep pads recall was issued in January due to possible contamination with the bacteria Bacillus cereus, which could cause serious and potentially life-threatening infections.

That action was followed by a recall of Triad sterile lubricating jelly earlier this month due to concerns that it may not be sterile. However, according to an MSNBC report, FDA inspectors are now reporting that they have observed problems throughout Triad’s product line, which may raise concerns about other products manufactured by Triad.

According to inspectors most recent reports, Triad Group employees packed acne pads into containers with bare hands, water pipes used in making mouth wash and glycerin suppositories were infested with microbial contamination, and workers were caught failing to add the active ingredient to children’s cold medicine and then claiming they had added it.

FDA investigators have been aware of sterility problems at Triad Group’s Wisconsin manufacturing facility since at least July 2009, but say they only realized there was a public health threat late last year following reports of Bacillus cereus contamination of alcohol prep pads used to clean injection and surgical sites from a Colorado hospital.

The alcohol prep pads and wipes were commonly used in hospitals and packaged with a number of medications. They were sold under the Triad brand name, as well as under variety of other labels, including CVS, Walgreens and Cardinal Health.

Since the Triad recall was announced, the FDA has received at least 100 additional reports from consumers who have had problems with the alcohol prep pads and wipes. Bacillus cereus on the alcohol prep pads could cause skin infection, or if the bacteria is pushed into the skin after the surface is cleaned with one of the wipes, it could result in potentially life-threatening infection.

At least two Triad alcohol prep pad lawsuits have been filed in recent weeks, including a Bacillus cereus infection wrongful death lawsuit filed by the family of a two-year-old Houston boy who died after becoming infected by the contaminated alcohol wipes.