Recalled Motrin Infant Drops, Children's Motrin Suspensions
Motrin Infant Drops and Children's Motrin Suspensions were among dozens of children's over-the-counter drugs recalled by Johnson & Johnson's McNeil Consumer Healthcare unit on April 30, 2010. If your child became sick, or suffered an unusual reaction after taking Motrin Infant Drops or Children's Motrin Suspensions, the medication might be to blame. Drugs involved in that recall have been associated with hundreds of adverse reaction reports made to the U.S. Food & Drug Administration (FDA), some of which involved fatalities.
The FDA has blamed the recall on shoddy manufacturing practices by McNeil. An FDA inspection of the McNeil facility where Motrin Infant Drops, Children's Motrin Suspensions, and other recalled drugs were made revealed substandard conditions. These included bacterial contamination of ingredients and filthy equipment at the plant. During a Congressional hearing into the recall, officials with the FDA said Johnson & Johnson had demonstrated a pattern of failing to control product quality at its McNeil Consumer Healthcare unit and was under criminal investigation as a result.
If you believe your child was injured by Motrin Infant Drops or Children's Motrin Suspensions, your family may be entitled to compensation. Please call us to arrange for a free, no obligation lawsuit consultation today.
Johnson & Johnson Children's Medicine Recalls
Popular over-the-counter children’s medications made by Johnson & Johnson's McNeil Consumer Healthcare unit have been associated with hundreds of adverse event reports, including deaths. If your child became sick after taking Tylenol Infant Drops, Children’s Tylenol Suspensions, Children’s Tylenol Plus Suspensions, Motrin Infant Drops, Children’s Motrin Suspensions, Children’s Zyrtec Liquid in Bottles, or Children’s Benadryl Allergy Liquid, the medication could be to blame.
On April 30, 2010, more than 40 varieties of these medications were recalled. Johnson & Johnson said that some of the children's medicine may have been made with a higher concentration of active ingredient than the label specified, while others contained particulate matter. At the time, the recall was the largest involving children's medicines in the history of the FDA, and involved 70 percent of the market for over-the-counter pediatric liquid medicines.
When the recall was issued, the FDA said it found 20 manufacturing violations at the McNeil Consumer Healthcare plant where these children's medications were made. It is outrageous that Johnson & Johnson allowed conditions to exist at the McNeil manufacturing facility that put children at risk! If your child was sickened by one of these defective Johnson & Johnson medications, you deserve compensation. Filing a lawsuit to recover damages on behalf of your child is one way you can hold Johnson & Johnson accountable for its failure to safeguard the health of millions of children whose parents unwittingly gave them these dangerous drugs. We urge you to contact our firm today for a free lawsuit consultation.
Johnson & Johnson Recall Resulted from Shoddy Manufacturing
Johnson & Johnson's disregard for safety may have had serious consequences for hundreds of children. According to a congressional committee investigating Johnson & Johnson’s manufacturing practices, the FDA received 775 adverse event reports - including 30 involving deaths - related to use of the recalled medications between January 2008 and April 2010. After the recall, the agency received several hundred more complaints, including seven more fatalities.
An FDA inspection report from late April 2010 makes it pretty clear why these medicines were defective. The report details poor conditions and shoddy manufacturing practices at the Port Washington, PA facility where the drugs were made. These included bacterial contamination of ingredients and filthy equipment at the plant. They also found that some medications made at the plant were overly concentrated and "had the potential to be superpotent." What's more, the agency said McNeil failed to initiate corrective action after receiving 46 consumer complaints from June 2009 to April 2010 regarding foreign materials in the drugs. The findings were so disturbing that the FDA expanded its investigation to include all of McNeil's manufacturing facilities.
Unfortunately, the April 30 recall was not the first time that ongoing, systemic failures at a McNeil facility put consumers at risk. In fact, that recall marked the company's third recall of over-the-counter medications since September 2009. That month, McNeil recalled more than 50 children’s and infants’ Tylenol products after the bacteria Burkholderia cepacia (B. cepacia) was detected in an “inactive ingredient” in products manufactured between April and June 2008.
The following November, McNeil recalled 5 lots of Tylenol Arthritis Pain Caplet 100 count bottles, with the distinctive red EZ-OPEN CAP following consumer reports of a musty odor, which was associated with nausea, stomach pain, vomiting and diarrhea. That recall was expanded in December to include all lots of the Tylenol Arthritis Pain Caplets. The same recall was expanded yet again in January to include various lots of Tylenol, Rolaids, Benedryl and St. Joseph’s Aspirin. In total, the expanded recall included about 50 million bottles of the medications.
Leal Help for Victims of Johnson & Johnson's Defective Drugs
Parents should not have to worry about the safety of the medicines they give their children. Had Johnson & Johnson and McNeil not been negligent in their manufacturing practices, the recalls and adverse reactions possibly linked to the drugs could have been avoided. It is important that Johnson & Johnson and McNeil pay a price for this outrageous behavior.
If you think your child was sickened by a tainted Johnson & Johnson drug, we want to hear from you today. Please fill out our online form or call 1 800 LAW INFO (1-800-529-4636) for your free lawsuit consultation.