Huge Baby Children Product Recall Johnson & Johnson
Filed under: Bad Drugs, Banned Foods, Children Products Recalled, Product Recalls, Recall
A division of Johnson & Johnson is recalling 43 over-the-counter medicines made for infants and children — including liquid versions of Tylenol, Motrin, Zyrtec and Benadryl — after federal regulators identified what they called deficiencies at the company’s manufacturing facility.
The voluntary recall, which was announced late Friday by McNeil Consumer Healthcare, affects hundreds of thousands of bottles of medicine in homes and on store shelves throughout the United States and its territories and in nine other countries — a vast portion of the children’s medicine market.
The Food and Drug Administration is advising parents and caregivers to stop using the affected products, although Commissioner Margaret A. Hamburg called the potential for serious health problems resulting from the medications “remote.”
FDA inspectors had begun a routine inspection April 19 in the company’s Fort Washington, Pa., plant when they noticed “manufacturing deficiencies” that triggered the recall, said Douglas Stearn, a senior FDA official.
Stearn said the plant’s manufacturing process was “not in control,” a term regulators use to describe flawed procedures that affect the composition of medicine. Federal investigators do not know when the problems at McNeil began, but Stearn said that “this does go back in time” and that “we have to try to figure that out.”
While the FDA investigates, McNeil has suspended operations at the facility. In a statement, the company said: “Some of the products included in the recall may contain a higher concentration of active ingredient than is specified; others contain inactive ingredients that may not meet internal testing requirements; and others may contain tiny particles.” It said the problems may affect “purity, potency or quality.”
Marc Boston, a McNeil spokesman, would not discuss the deficiencies cited by the FDA or say when the manufacturing facility was shut down. The company also declined to disclose the amount of products affected by the recall. In addition to the United States, Puerto Rico and Guam, the medicines were sold in Canada; the Dominican Republic; Dubai, in the United Arab Emirates; Fiji; Guatemala; Jamaica; Panama; Trinidad and Tobago; and Kuwait.
A complete list of recalled products is on the company’s Web site.
McNeil received consumer complaints associated with some of the recalled medicines, but the company’s decision to pull them was not made on “the basis of adverse medical events,” said Boston, who declined to elaborate.
If a child who has taken any of the recalled medications exhibits any unexpected symptoms, parents or caregivers should contact a doctor, federal officials said. Consumers or health-care providers who experience problems connected to the recalled medicines are asked to contact the FDA.
As of Saturday, the FDA was not aware of any health problems related to the recalled products, said spokeswoman Elaine Gansz Bobo.
Parents and caregivers can use generic versions of the affected medicines; they are not affected by the recall. The FDA cautioned against giving adult versions to infants and children, noting the potential for serious problems.
This is at least the third major recall of Tylenol products by McNeil since 2008.
In January, McNeil recalled 49 types of Tylenol products made for adults and two Tylenol products made for children after consumers complained of a mold-like odor and of temporary and minor nausea, stomach pain, vomiting and diarrhea. The company determined that some of the medicines had been contaminated by trace amounts of a chemical that is sometimes present on shipping and storage material.
In 2008, McNeil recalled 21 types of children’s and infants’ Tylenol liquid products, saying that although the products met internal standards, an unused portion of one inactive ingredient did not meet all quality standards
BPA – Can you really trust the FDA?
FDA’s objectivity regarding BPA questioned
10/27/2008 4:29:38 PM
WASHINGTON — Federal lawmakers are investigating the relationship the US Food and Drug Administration (FDA) may have with the chemical industry regarding the FDA’s draft assessment that bisphenol A (BPA) is safe, an October 24 USA Today article reports.
The congressional action was launched in part after The Milwaukee Journal Sentinel reported that the FDA’s assessment of BPA was based on reports from the plastics industry and those with a financial stake in the chemical used to harden plastics, such as polycarbonate water bottles.
The findings of the FDA draft report are at odds with the conclusions of the FDA’s own advisers from the National Toxicology Program (NTP), who announced in September that the chemical is of “some concern” relating to the development of the brain, behavior and the prostate gland in fetuses, infants and children.
The Journal Sentinel reported that the FDA will not reveal who prepared its draft assessment on BPA, but FDA documents obtained by the newspaper show that the work was done primarily by those with ties to the chemical industry, including Stephen Hentges of the chemical manufacturer trade association American Chemistry Council’s group on bisphenol A.
The newspaper reported that Hentges commissioned a review of all studies of the neurotoxicity of the chemical and submitted it to the FDA. “The FDA then used that report as the foundation for its evaluation of the chemical on neural and behavioral development,” the Journal Sentinel reported.
The Journal Sentinel also reported that the congressional committee also is evaluating the role that an FDA-hired consulting group, Virginia-based ICF International, had in preparing the draft. Other ICF clients include the American Chemistry Council and the American Petroleum Institute.
Also being scrutinized is the fact that the chairman of the FDA subcommittee that is reviewing the FDA’s assessment of BPA heads a research center that has accepted a $5 million gift from a retired medical device manufacturer who says BPA is safe. BPA is used in the manufacture of some medical devices.
The Journal Sentinel reported that FDA subcommittee chairman Martin Philbert received $5 million from Charles Gelman, who told the Journal Sentinel that he had expressed his views that BPA is “perfectly safe” to Philbert in several conversations. “Philbert at first denied ever having been contacted by Gelman about bisphenol A. He now says that he is aware of Gelman’s views but is not influenced by them,” the newspaper reported.
The subcommittee’s review of the BPA report was expected to be released any day with a presentation in Washington on October 31. Consumer advocacy groups, including the Environmental Working Group (EWG), have said that many scientific studies suggest BPA may cause serious harm. The EWG issued a statement on October 23 saying that the Journal Sentinel’s investigative report “proves a glaring conflict of interest that should render the draft meaningless.”
The Canadian government on October 18 declared that BPA is a toxin and that it is banning its use in baby bottles, as WaterTech Online™ reported, and attorneys general from Connecticut, New Jersey and Delaware have asked 11 companies to stop using BPA in baby bottles and formula cans, USA Today reported.
To read the full USA Today article, click here.
To read the full Journal Sentinel report, click here.
For related information on this story, click here.
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