For the second time in less than one month, Johnson & Johnson Company, the makers of Tylenol, have added another medication to the recall list of over-the-counter medication. The recall now includes select batches of regular and extra-strength Tylenol, children’s Tylenol, eight-hour Tylenol, Tylenol Arthritis, Tylenol PM, Children’s Motrin, Motrin IB, Benadryl, Rolaids, Simply Sleep and St. Joseph’s aspirin. Additionally, caplet and gel tab products from North and South America, United Arab Emirates, along with Fiji were recalled.
Medication was initially reported because consumers were reporting a moldy smell that had made a few consumers sick. This past November, Johnson & Johnson’s McNeil Consumer Healthcare Products announced a recall on select Tylenol Arthritis Caplets due to the reported smell that was causing diarrhea, nausea, stomach pain, and vomiting.
According to the FDA, McNeil Consumer Healthcare did not move fast enough on recalling the defective medication. The company was aware of the issues in early 2008, however they did not conduct a full investigation, according to the FDA. The agency reported that around 70 people were sickened by the smell or at least noticed the odor of the medication. The Director of the FDA’s Office of Compliance of the Center for Drug Evaluation and Research said that the company should have reacted sooner and that, “When something smells bad, literally or figuratively, companies must aggressively investigate and take all necessary action to solve the problem.”
A warning was sent the McNeil Consumer Healthcare for violation of manufacturing standards and failing to report and investigate the problem in a timely manner. The FDA is demanding an explanation as to why the problem was not publically announced earlier. To get a complete list of the recalled medications, please check out our Toledo, Ohio lawyers’ Tylenol recall list.