Triad’s recent recall of 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, is quite disturbing. At least two lawsuits are pending over use of the pads that caused injury. H&P Industries, doing business as the Triad Group, provides generic medical products sold under private labels of grocery stores such as Safeway and Kroger and drugstores such as CVS and Walgreens.
Documents that have become available reveal that 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. 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 for other products used for intimate care. Those include hemorrhoid creams, infant and adult glycerin suppositories and sterile lubricating jelly 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. But, the inspectors said Triad’s processes “may not be adequate to sterilize” the lubricating jelly. They also charged that Triad had failed to address “high microbial bioburden levels” previously detected in the purportedly-sterile jelly. Interestingly, information about the specific type of contamination was redacted in the documents. It appears that while the inspection process was working, neither the company nor FDA followed up to prevent the injuries that may have resulted from these products. The reason for the recalls is quite disturbing since it appears that both Triad and the FDA dropped the ball. The conditions discovered are alarming and point to a serious safety concern at Triad. Interestingly, the FDA has defended its delay in dealing with the safety issues at Triad.
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