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Recent Recalls of Tylenol Result from Serious Quality Control Issues

February 11, 2011

A recent wave of recalls of Tylenol and other over-the-counter medications are related to admitted quality control and manufacturing issues. McNeil Consumer Products, which is a subsidiary of Johnson and Johnson, has issued multiple product recalls of Tylenol (generic “acetaminophen”) since late 2009.

The recalls have been linked to a variety of issues ranging from unusual odors to an excess of acetaminophen, the active ingredient in Tylenol. These quality control and manufacturing issues are of particular concern because of well-documented links between Tylenol and liver failure as well as kidney impairment. Because liver damage and kidney impairment from Tylenol is a particular concern for consumers who have taken higher doses, the recalls associated with quality control issues related to the amount of acetaminophen in various versions of Tylenol pose a serious danger to consumers. At Montlick and Associates, Attorneys at Law, we protect the rights of people who have suffered serious medical conditions and injuries resulting from the use of defective medications, including potentially harmful over-the-counter drugs like Tylenol.

Late last year, federal officials shutdown McNeil’s Ft. Washington, PA plant that was the exclusive manufacturer of children's and infants' Tylenol, Motrin and other popular over-the-counter pediatric medicines. The FDA indicated that the plant lacked quality controls, used raw materials contaminated with bacteria and failed to investigate consumer complaints that some medicines were contaminated with black particles. While such reports may be hard to believe, this lack of quality control is concerning because Tylenol has a clearly established toxic effect on the liver and kidneys, which is particularly serious when taken in large doses. When the manufacturer is placing versions of the drug on the market that possess an excess of acetaminophen which causes liver failure and kidney damage, consumers have a reason to be concerned.

In the wake of the shutdown of the Ft. Washington plant, the company announced a voluntary recall of 43 over-the-counter pediatric medicines in the United States, its territories and nine other countries. The recall affected Tylenol, Motrin, Zyrtec and Benadryl, popular medications for pain, cold and allergy relief. Many over-the-counter cold medicines also include acetaminophen and can result in a danger of acetaminophen overdose when taken in combination with Tylenol. Consumers should not assume this is an isolated mishap because the reason for the investigation of the Ft. Washington plant was that similar quality control issues were discovered in the company’s Puerto Rico plant. The FDA specifically identified defects in McNeil's quality-control methods and manufacturing processes, including a failure to track consumer complaints and identify signs of systemic deficiencies, a lack of written production protocols and inadequate employee training.

If you or someone you love has suffered serious injuries as a result of your use of Tylenol/Acetaminophen, such as liver injuries, liver failure or impairment of your kidneys, contact Montlick and Associates, Attorneys at Law, for a free consultation to discuss your rights to compensation. Serious quality control issues, that can lead to an overdose of acetaminophen resulting in severe kidney and liver injuries, are inexcusable. We know that the best way to prevent such shoddy manufacturing practices is to hold drug companies responsible for the negative consequences resulting from their defective drug manufacturing practices. If a dangerous or defective drug has injured you, Montlick and Associates can help.

Our experienced Georgia Tylenol Injury Claim attorneys are available to assist clients throughout all of Georgia and the Southeast, including but not limited to Albany, Athens, Atlanta, Augusta, Columbus, Gainesville, Macon, Marietta, Rome, Roswell, Savannah, Smyrna, Valdosta, Warner Robins and all smaller cities and rural areas in the state. No matter where you are located we are just a phone call away, and we will even come to you. Call us 24 hours a day/7 days a week for your Free Consultation at 1-800-LAW-NEED (1-800-529-6333). You can also visit us online at and use our Free Case Evaluation Form or 24-hour Live Online Chat.

Category: Personal Injury

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All information provided by our blogs is general in nature and should not be relied upon as legal advice. Consult a Montlick attorney for details about your unique situation.