FDA Indictment of J&J Product Quality
Tylenol Update 5/25/12: According to the results of a new study, hospitals are providing patients with excessive doses of acetaminophen at alarming rates. The active ingredient found in Tylenol, acetaminophen has recently been linked to liver damage, liver failure, and death. Click here to learn more.
Tylenol Update 3/8/12: Tylenol has recently been linked to severe liver damage, liver failure, and other serious liver injuries. Each year, the acetaminophen contained in Tylenol is associated with over 800 cases of liver failure in the United States alone. Click here to learn more.
Medical News Update 1/17/2011 – Johnson & Johnson’s McNeil unit is now recalling 47 million packages of over-the-counter brands including Tylenol, Sudafed, Benadryl, Rolaids, and Sinutab. If you’d like specific products and lot numbers covered by this nationwide recall, please visit the McNeil recall website.
Free Tylenol Recall Case Evaluation: If you or a loved one has been injured by Tylenol, you should contact our law firm immediately. You may be entitled to compensation by filing a lawsuit and we can help.
What’s the problem?
This week, J&J announced a store-wide recall of its children liquid products under its Tylenol, Zyrtec, and Benadryl brands. The recall of 44 sku’s and 1,500 product lots is the fourth recall in seven months involving their key OTC brands. The fact that these products target infants makes the insouciance even more reprehensible.
The U.S. FDA cites J&J with the following failures in: manufacturing process, laboratory testing, consumer complaint handling, follow up investigation of problems, training, labeling, raw material handling, stability, bacterial contamination, levels of active ingredients, test procedures, calibration, sampling, storage, and equipment maintenance.
Important to note is that these recalls appear to be the result of widespread gross systemic failures in their quality control system rather than a series of isolated incidents. The release of so many tainted products with varying levels of active ingredients, raw material problems, and particulate contaminants reflects complete failure of basic procedures designed to prevent adultered product release. Also worth noting is that this latest FDA plant audit reveals that these failures occurred across at least two plants and many product forms.
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