On April 30, 2010, the FDA charged that McNeil Consumer Healthcare knew about many of the contamination problems in one of its U.S. manufacturing plant before McNeil voluntarily recalled a number of certain over-the-counter Infants’ and Children’s liquid products. McNeil voluntary recalled these products for a number of reasons, including because the recalled products may contain a higher concentration of the active ingredient. In addition, the FDA reported that other products "may contain inactive ingredients that may not meet internal testing requirements; and others may contain tiny particles." McNeil advises that parents and caregivers who have purchased the recalled products (including Tylenol, Motrin, Benadryl and Zyrtec) to not administer them to children.
Following the April 30 voluntary recall, the Fort Washington, PA, manufacturing plant, located in suburban Philadelphia, suspended production as inspectors discovered contaminated ingredients, raw ingredients contaminated by an unspecified bacteria, in addition to dirty equipment, duct taped piping, and a hole in the facility’s ceiling. The Johnson & Johnson subsidiary issued a statement saying that the plant would not reopen until the company is able to assure that they are manufacturing quality products.
The FDA states that the chance of becoming sick by these products is "remote," however, parents and caregivers should discontinue their use.
As recently as January 2010, the FDA warned McNeil for being too slow to alert the FDA and consumers to trace amounts of a wood-treating chemical in some of its products, including its OTC drug Tylenol. The company first received complaints of a musty and moldy smell in certain drug products in September 2008 but did not notify the FDA until a year later, so the FDA issued McNeil a Warning Letter in January. McNeil recalled a number of its OTC products that may have been affected by this chemical.
If you believe that you have any of these contaminated medications please contact Sheller, P.C.