Itâ€™s been over six months since the global recall of Triad alcohol wipes, yet the wipes linked to serious illnesses and deaths are still on store shelves, as well as in home medicine cabinets.
The Journal Sentinel Online (JS Online) points out that the U.S. Food and Drug Administration (FDA) claims the global recall of tainted Triad wipes was effective, but will not release audit reports on the findings and measures taken by the two firms involved: Triad Group and H&P Industries, the company that manufactures for Triad.
The firms have been accused of manufacturing and distributing alcohol products that were allegedly tainted with deadly bacteria and which have led to serious reactions in already compromised patients. The dangerous bacteria linked to the productsâ€”Bacillus cereus and Elizabethkingia meningosepticaâ€”can lead to rare and deadly infections.
MSNBC previously noted that its ongoing investigation revealed the FDA was aware of contamination and sterilization problems back in 2009 and involving the alcohol prep pads and other products, stating that it remains unknown how long the FDA was aware of Bacillus cereus problems because the agency â€œheavily redacts inspection documents.â€ Regardless, said MSNBC, some redactions challenged by the Milwaukee Journal Sentinel revealed that the FDA documented the pathogen in â€œa multi-week inspection thatâ€ initiated last November. FDA officials finally admitted to senators Michael Bennet (Democrat-Colorado) and Lamar Alexander (Republican-Tennessee) that it should have taken â€œstronger action sooner,â€ wrote MSNBC.
When the FDA completed an inspection of the facility in March, multiple violations of cGMP requirements, including continuing problems with the air handling system, failure to adequately investigate drug products that did not meet specifications affecting the majority of the products manufactured at the facility, and failure to take the proper measures to ensure the quality of incoming components were revealed. The FDA previously asked H&P to stop manufacturing and distributing; it did not comply. H&P finally shut down operations shortly after the U.S. Marshalls descended on the plant.
Another firm that supplies wipes to hospitals has been found to have a history of manufacturing problems, as well, recalling wipes twice in the recent 18 months, said JS Online, which noted that shoddy product coding systems make it virtually impossible for hospitals, distributors, and consumers to identify and locate recalled items. In this case, for instance Triad wipes are being sold under a variety of brands, including Walgreenâ€™s, CVS, Cardinal Health, and Leader.
Another wipe supplier, Professional Disposables International of Orangeburg, New York, recalled over 19,000 cases of antiseptic wipes and towelettes in February because the active ingredient, benzalkonium chloride, was present in insufficient quantities, said an FDA enforcement report, wrote JS Online. Last August, a recall of 30 lots of Sani-Cloth Bleach Wipes was implemented over quality issues; in 2010, Professional Disposables recalled 403,266 packs of Up & Up baby wipes due to an uncharacteristic “off odor,” the FDA noted; and Nice-Pak, affiliated with Professional Disposables, issued a Class I recall of provodine wipes in 1999 over contamination with Salmonella, according to FDA documents, said JS Online.
At least one consumer said she attempted to contact Walgreenâ€™s, but the firm would not tell her if the box in her possession was part of the recall, said JS Online. She was told that Walgreenâ€™s said it had an agreement with the manufacturer not to release its name. She was later called by Triad and told to dispose of the swabs or return them to Walgreenâ€™s, said JS Online. In the meantime, she was met with hang-ups and incomplete information. JS Online said it purchased a Leader first aid kit containing alcohol wipes and that when it contacted Cardinal Health, Leaderâ€™s distributor; Triad; and H&P, no one could determine if the wipes were part of the recall or a replacement product.