Amid a new round of recalls of medical disinfecting wipes, a U.S. Food and Drug Administration inspection report of a pair of businesses at the center of the recalls detailed manufacturing violations that prompted the agency to seize more than $6 million in medical products at the Hartland, Wis., facilities.
Since December, Triad Group and its sister company, H&P Industries Inc., recalled a score of alcohol prep pads that it made for companies including Walgreens and CVS. The products were recalled because of potential contamination from bacillus cereus, a bacterium that could cause a potentially serious infection. Consumers who have to take medical injections -- like diabetics -- use prep pads to clean and disinfect their skin before the injections.The recalls have prompted a number of companies that include Triad products within their medical product kits to issue alerts to consumers telling them not to use the recalled products. Among those companies is the Wisconsin Pharmacal Co. which had included Triad Povidone Iodine Prep Pads in the Atwater Carey First Aid Kits it distributes. The company said today (April 25) the pads are no longer carried in the kits but that consumers should discard any pads from older kits.
Medical product makers Smith & Nephew and Eli Lilly Co. are among the latest companies to warn consumers not to use alcohol prep pads made by the Triad Group.
Smith & Nephew recalled certain lots of IV Prep Antiseptic Wipes with a product number of 59421200 made by the Triad Group for the company because of potential contamination. Smith & Nephew said it has had no reports of consumers sickened but began the recall anyway as a precaution. The company lists the lot numbers included in the recall on its website.
The company also recalled certain lots of its Remove adhesive remover wipes, Uni-Solve adhesive remover wipes, Skin-Prep protective wipes, Peri-Prep protective wipes and No-Sting Skin-Prep protective wipes. Smith & Nephew's website lists the product code numbers affected by that recall.
Eli Lilly also warned consumers not to use the alcohol prep pads in its Forteo injection starter kits that were packages in black bags and distributed between March 2008 and June 2009 (the kits have since been discontinued). The new starter kits come in blue bags and don't contain any alcohol prep pads.
H&P Industries products have been named in three lawsuits over a death and serious injuries from allegedly contaminated alcohol prep pads, according to MSNBC.com. The FDA has received 201 complaints connected to the products and is investigating seven deaths that could be connected with the Triad alcohol wipes.
The FDA inspected the now-closed H&P Industries in March and found, among other issues, problems with the air handling systems, as well as inadequate investigations of products that didn't meet the FDA's specifications. The FDA said U.S. marshals seized antiseptic products, cough and cold products, nasal sprays, suppositories, medicated wipes, antifungal creams and hemorrhoidal wipes from the companies. The FDA said after such actions, companies often will agree to change their manufacturing methods. The company has said it is working with the FDA and voluntarily closed its plant after the seizure of the products.
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