Raw materials used to make over-the-counter infant’s and children’s medications, which are subject to a massive recall, tested positive for bacterial contamination, according to a Food and Drug Administration inspection report released late Tuesday.
The report, which also found more than a dozen other violations at the facility used to make the products, detailed a series of sloppy manufacturing processes including failure to maintain equipment, properly train employees and correctly weigh ingredients. The report also indicates that the drug maker, Johnson & Johnson’s McNeil Consumer Healthcare subsidiary, failed to investigate “46 consumer complaints regarding foreign materials, dark or black specks,” some dating to June 2009.
“They’ve had a number of recalls and some observers are starting to question the integrity of the supply chain. The trend we’ve seen is not positive,” said industry analyst Les Funtleyder at Miller Tabak & Co.’
http://www.latimes.com/business/la-fi-tylenol-20100505,0,3649117.story
‘Food and Drug Administration inspectors found in April that McNeil Consumer Healthcare, which has voluntarily recalled certain lots of its children’s and infants’ Tylenol products, knowingly used bacteria-contaminated materials to make them, a report posted Tuesday by the agency says.’
http://www.usatoday.com/news/health/2010-05-04-tylenol-plant_N.htm?csp=34
FDA REPORT: ‘McNeil Consumer Healthcare and FDA notified healthcare professionals of a voluntary recall of certain over-the-counter (OTC) Children’s and Infants’ liquid products manufactured in the United States, including Tylenol, Motrin, Zyrtec, and Benadryl products. McNeil Consumer Healthcare is initiating this voluntary recall because some of these products may not meet required quality standards. This recall is not being undertaken on the basis of adverse medical events. However, as a precautionary measure, parents and caregivers should not administer these products to their children. Some of the products included in the recall may contain a higher concentration of active ingredient than is specified; others may contain inactive ingredients that may not meet internal testing requirements; and others may contain tiny particles. While potential for serious medical events is remote, the company advises consumers who have purchased these recalled products to discontinue use.’
http://www.fda.gov/Safety/Recalls/ucm210443.htm
Product Brands On Recall List –
TYLENOL: http://www.tylenol.com/products/infants-tylenol-oral-suspension
MOTRIN: http://www.motrin.com/page.jhtml?id=/motrin/include/prd_motrin_ndcfinder.inc
ZYRTEC: http://zyrtec.com/econsumer/zyrtec/press.view?body=/zyrtec/pages/ndc_finder.jsp
BENADRIL: http://www.mcneilproductrecall.com/page.jhtml?id=/include/new_recall.inc
FDA FINDINGS ON MCNEIL: LIST OF VIOLATIONS OF SAFETY & PUBLIC TRUST:
A) Failure to investigate “46 consumer complaints regarding foreign materials, dark or black specks,” some dating to June 2009.
B) Failure to maintain equipment, properly train employees and correctly weigh ingredients.
C) 50 variations of infant’s and children’s Tylenol, Motrin, Zyrtec and Benadryl tested positive for bacterial contamination.
D) The report documents “numerous deficiencies,” including “a failure to sufficiently investigate problems in its manufacturing and in its drugs,” failure to maintain proper testing facilities, and making changes in manufacturing processes without assuring that they would not harm consumers.
E) According to USA Today McNeil KNOWINGLY used bacteria-contaminated materials to make them.
F) The inspection was triggered at least in part by a warning letter sent to a McNeil plant in Puerto Rico in January in connection with another recall involving medications tainted by a chemical found in wooden shipping pallets. A foul odor associated with the chemical temporarily sickened about 70 people. In that letter, FDA cited ongoing concerns with the company’s quality control.
G) The weekend recall was the ninth product recall for McNeil this year, according to FDA figures.
FDA VERDICT: ‘No decision has been made about what further action, if any, the FDA will take, officials said. Options range from sending a warning letter to seeking criminal penalties.’
The FDA routinely turns a blind eye to Big Pharma malfeasance. Frequently major violators are given nothing more than a token slap on the wrist; their product then quietly diverted to countries outside the ire of the spotlight – always accompanied by a Media blackout.
A landmark case – Bayer Corporation, owned by Nazi sympathizer I.G.Farben, were caught red handed distributing Factor 8 (a blood clotting agent for Hemophiliacs) tainted with the HIV Aids virus to tens of thousands of hemophiliacs in the United States. The FDA imposed a toothless ban with the assurance Bayer would clean up their act. The CEO’s at Bayer avoided any serious recrimination. Within weeks the tainted supplies were quietly shipped for sale to Europe, Asia & Latin America. The vast majority of victims around the world suffered and/or died in silence. Finally in 1997 Bayer was pinned down in Court; with thousands of hemophiliacs involved compensated $100,000 each. However most never saw such token justice.
‘Four drug manufacturers whose blood products were said to have infected thousands of hemophiliacs with the virus that causes AIDS in the early 1980’s will pay about $670 million in a settlement approved by a Federal judge. Six thousand hemophiliacs were each to receive $100,000. In an earlier settlement in Japan, AIDS-infected hemophiliacs were paid $450,000 each. The office of Federal District Judge John Grady confirmed today that he had granted oral formal approval to the settlement on Tuesday. The settlement had won preliminary court approval in April 1996.
The settlement was ”one of the most horrible scenarios that can be imagined,” said Ron Niederman, a spokesman for the Committee of 10 Thousand, which represents the hemophiliacs. ”In light of the damage they caused, the companies are getting off cheap.”
The companies, which admitted no wrongdoing but agreed to settle, were Bayer A.G. of Germany, the Green Cross Corporation of Japan, Rhone-Poulenc Rorer Inc., a French and American company and Baxter International Inc. of Deerfield, Ill.’
http://www.nytimes.com/1997/05/08/business/4-drug-companies-ordered-to-pay-hemophiliacs.html
‘The FDA, especially in the area of antidepressants, has long been seen by much of the scientific community as compromised by drug company influence and it is decreasingly recognized as a serious regulatory agency. In a 1991 FDA “blue ribbon” panel investigating the association between Prozac-type antidepressants and violence, five of the nine FDA panel doctors had ties to pharmaceutical corporations. The panel voted not to require these antidepressants to display a violence warning label. This was aided by Paul Leber, director of the FDA’s Division of Neuropharma- cological Drug Products, who in the late 1990s left the FDA to direct a consulting firm that specializes in advising pharmaceutical companies that are attempting to gain FDA approval for new psychiatric drugs.
The revolving door of employment between the FDA and Big Pharma resembles other governmental-industrial arrangements where regulatory favors routinely result in future industry income. In 2001 The Lancet, Great Britain’s respected medical journal, described the FDA as a “servant of industry.”
Before approving a drug, the FDA does no research on that drug. Instead, the FDA evaluates studies handed to them by the pharmaceutical company that created the drug. Despite repeated evidence of untrustworthiness and outright fraud, the FDA continues to trust Big Pharma data.’
http://brucelevine.net/zmag-behindpaxilscandals-levinepr0405.htm
‘Even if McNeil had been operating up to proper standards, many of its children’s formulations are still filled with questionable chemical ingredients like aspartame, high-fructose corn syrup, sucralose (Splenda), artificial colors and preservatives, and even parabens, all of which are approved by the FDA for use in children’s and infants’ formulas.
The shocking truth is that, even in their approved and “safe” forms, most OTC children’s medicines are nothing more than dangerous chemical cocktails being peddled as medicine. They’re filled with so much harmful garbage that they can hardly be considered beneficial. Most of them are outright useless. These OTC children’s medicines are the quackery of modern medicine.’ Mike Adams, Natural News
http://www.naturalnews.com/028732_Tylenol_recall.html
“Tylenol uses up glutathione (GSH) stores and metabolites of acetaminophen accumulates causing direct damage to liver cells. You want their glutathione levels to be optimum because GSH main purpose is for detoxifying and eliminating heavy metals and other environmental toxins. It is essential for the function of the gut, maintains Vitamins C and E, maintains mitochondrial integrity, protects against intracellular viruses and so much more. Anything that compromises the level of glutathione needed to maintain health like Tylenol should be avoided.” Brian Jepson, MD
‘Acetaminophen overdose is the leading cause for calls to Poison Control Centers (>100,000/year) and accounts for more than 56,000 emergency room visits, 2,600 hospitalizations, and an estimated 458 deaths due to acute liver failure each year. Data from the U.S. Acute Liver Failure Study Group registry of more than 700 patients with acute liver failure across the United States implicates acetaminophen poisoning in nearly 50% of all acute liver failure in this country. Available in many single or combination products, acetaminophen produces more than 1 billion US dollars in annual sales for Tylenol products alone. It is heavily marketed for its safety compared to nonsteroidal analgesics. By enabling self-diagnosis and treatment of minor aches and pains, its benefits are said by the Food and Drug Administration to outweigh its risks. It still must be asked: Is this amount of injury and death really acceptable for an over-the-counter pain reliever?’
http://www.ncbi.nlm.nih.gov/pubmed/15239078
‘People who take NSAIDs for prolonged periods of time can develop several GI side effects, such as stomach aches, indigestion, or even ulcers. Ulcers can eventually lead to GI bleeding or may even perforate, spilling the contents of the stomach or small intestine into the sterile abdominal cavity. Every time they come in with bleeding, they have a 10% chance of dying.’ Dr. Joseph Mercola
ASPIRIN impairs Thyroid function, depleting the Vitamin C levels of the white bloods & lymphocytes in the lungs. The flu virus triggers this weakness causing hemorrhaging in the lungs.
Aspirin not only suppresses the fever (a critical stage in getting well again – essential part of the body’s own natural healing process) but it also destroys the liver over time & can cause sudden bleeding. This weakness can lead to Pulmonary Edema in worst cases.
Most people who catch the flu die of bacterial pneumonia, NOT from the flu itself.
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VRM Live – 01/28/11: Vaccine Resistance Movement founder Joel Lord discusses Synthetic Genomics, cloned cell vaccine technology & the death of natural immunity, gutter journalism & Dr. Wakefield’s imminent vindication with ‘Truth to Power’ host Paul Mabelis.
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