PDI Alcohol Wipe Recall Should Have Happened Earlier: FDA

Federal regulators say that a lack of cooperation led to a four-month delay in recalling bacteria-tainted alcohol wipes and prep pads by Professional Disposables International (PDI), but the company claims it is the victim of an agency that moved the goalposts without warning. 

Both the FDA and PDI officials agree that Bacillus cereus bacteria was detected on the New York manufacturer’s non-sterile alcohol prep pads and wipes in June, almost four months before a alcohol prep pad recall was announced.

FDA officials now say that the wipes should have been recalled sooner, but the action was delayed as the agency tried to wrestle the company into protecting public safety, according to a report in the Milwaukee Journal Sentinel.

The incident highlights the FDA’s lack of power to quickly force a recall of dangerous products from the marketplace. Currently, the FDA must go to federal court and obtain a court order to force a recall on its own, so it relies heavily on voluntary recalls and full disclosure by the companies whose products fall under the agency’s jurisdiction.

PDI officials maintain that the company was fully cooperative, but claim that the FDA moved the regulatory target in order to force it to recall. PDI officials say that originally the amounts detected on the nonsterile alcohol pads were not considered to be at levels that would require a recall. They claim that earlier this month the FDA changed the amount of bacteria that needs to be detected on nonsterile wipes to consider them a danger to public health.

The FDA’s enforcement actions have been under scrutiny since a Triad alcohol wipe recall was issued earlier this year for millions of similar products manufactured by H&P Industries. Following that recall, which has been associated with at least 8 deaths, it was revealed that the FDA knew there were problems for years at H&P Industries’ manufacturing plant in Wisconsin, where the Triad products were made. However, it was not until The Children’s Hospital in Colorado reported problems with the wipes late last year that a recall was initiated.

In the latest alcohol wipe recall, there were also a number of FDA inspections in the months leading up to the wipes being pulled from shelves. FDA inspectors found problems at PDI’s New York plant over the course of eight inspections, but in this case the FDA claims PDI promised to recall the contaminated wipes when Bacillus cereus was detected. However, PDI contests that version of the story, saying that a recall was not even discussed at the time because the levels of Bacillus cereus, the same bacteria that led to the Triad wipes recall, were so low.

Bacillus cereus is responsible for about two percent of all foodborne illness, according to the U.S. Centers for Disease Control and Prevention (CDC). Illness comes within 24 hours after exposure and can result in a diarrheal illness. Serious illness and permanent injury are very rare. There have been no reported illnesses linked to contaminated PDI alcohol wipes.