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FDA Cites Tylenol Manufacturer Yet Again for Safety Failures at Puerto Rico Plant

By December 2, 2010July 23rd, 2019Dangerous Drugs

As a dangerous drug attorney, I’ve written multiple posts in this space about recalls of over-the-counter medicines made by McNeil Pharmaceuticals. The company, a division of Johnson & Johnson, makes major over-the-counter drug brands such as Tylenol, Motrin and Benadryl. It hit the news in 2010 because of recurring safety problems at plants in Puerto Rico and Pennsylvania, leading to recalls of hundreds of millions of bottles of medicine. The U.S. Food and Drug Administration and members of Congress are separately investigating the company. Now, the New York Times reported Nov. 27, the U.S. Food and Drug Administration has made public a report showing that at least some of the safety problems at the plant have not been corrected.
The inspection was of a Puerto Rico manufacturing plant that had also been inspected in January of this year and found to have serious safety problems. The newer inspections, which took place between September and early November, show that some of those problems have not been addressed. Among the recurring problems in the November report (PDF) were failure to thoroughly investigate problems with products and failure to detect them in the first place. The report also found inadequate equipment cleaning and controls, which could lead to contamination or confusion of drugs. Procedures intended to prevent these problems were not being followed, the inspection report said. McNeil has reportedly already responded to these inspection reports. The FDA has said it won’t issue another warning letter, suggesting that more stringent enforcement actions may be taken.
Now is the right time for more serious regulatory action, in my opinion as a defective medication lawyer. McNeil has had most of a year to respond to the inspections, and apparently has failed to take steps to solve some serious safety problems. The inadequate procedures cited in the report are important because these procedures are what stands between the public and drugs that are not safe. In fact, because McNeil has had two consumer safety recalls in the last year, the danger is not just theoretical — failure to correct procedures stands a good chance of failing to stop unsafe drugs from hitting stores. This could put everyone who buys an over-the-counter medicine from McNeil in danger — and that’s millions of Americans. If McNeil does not make drastic changes quickly, the FDA should step in for the safety of the public.
Consumers trust name-brand over-the-counter drugs to help them feel better when they’re sick. But when companies allow contaminated, ineffective or otherwise flawed drugs to reach the market, consumers can be made sicker by the medicine that’s supposed to help. My firm,

Carey, Danis & Lowe, represents people who got sick or were injured by taking drugs they thought they could trust. Our pharmaceutical liability attorneys handle cases involving prescription drugs and medical devices as well as over-the-counter drugs and dietary supplements. Our clients pursue individual cases as well as joining class-action cases that bring together many people with the same complaints about the same medication. In addition to holding pharmaceutical companies legally liable for their actions — putting profits ahead of public safety — our clients can claim financial compensation for their injuries, illness, medical bills, lost income and more.
If you believe you were sickened by a drug that was supposed to help, you should call us today to discuss how we can help. To learn more or set up a free consultation, call us toll-free at 1-877-678-3400 or send us a message online.