Claim: Heparin recalled in France, Italy, Denmark: report.
Verdict: SUPPORTS

Retrieved passages:
title: 2008 Chinese heparin adulteration
text: 2008 Chinese heparin adulteration In March 2008, major recalls of heparin, a substance widely used as an injectable anticoagulant, were announced by the U.S. Food and Drug Administration (FDA) due to contamination of the raw heparin stock imported from China. The raw material for the recalled heparin batches was processed in China from pig's intestines by the American pharmaceutical firm Scientific Protein Laboratories. The U.S. Food and Drug Administration was quoted as stating that at least 81 deaths were believed to be linked to a raw heparin ingredient imported from the People's Republic of China, and that they had also

title: 2008 Chinese heparin adulteration
text: are fully responsible for qualifying their suppliers through on-site audits, testing, and regular communications. This ongoing responsibility is essential to ensure supply chain security, drug quality and drug safety, These basic commitments to the pharmaceutical consumer can only be ensured by adherence to Good Manufacturing Practice and Good Distribution Practice. 2008 Chinese heparin adulteration In March 2008, major recalls of heparin, a substance widely used as an injectable anticoagulant, were announced by the U.S. Food and Drug Administration (FDA) due to contamination of the raw heparin stock imported from China. The raw material for the recalled heparin batches was processed

title: Counterfeit medications
text: from which they were exported to U.S. wholesale distributors. The Wall Street Journal reported that the U.S. wholesale distributor was hired by Canada Drugs, which also owns CanadaDrugs.com, a retail pharmacy website that sells prescription medication internationally, with a focus on the American market. In 2007-08, 149 Americans died from a contaminated blood thinner called Heparin that was legally imported into the United States. Investigated by the FDA Office of Criminal Investigations, the Albers Medical investigation is the most prolific example to date. On August 21, 2005, the U.S. Attorney’s Office for the Western District of Missouri issued a press

title: Heparin
text: biological activity that influences the anticoagulation effect of heparin. In December 2007, the US Food and Drug Administration (FDA) recalled a shipment of heparin because of bacterial growth ("Serratia marcescens") in several unopened syringes of this product. "S. marcescens" can lead to life-threatening injuries and/or death. In March 2008, major recalls of heparin were announced by the FDA due to contamination of the raw heparin stock imported from China. According to the FDA, the adulterated heparin killed nearly 80 people in the United States. The adulterant was identified as an "over-sulphated" derivative of chondroitin sulfate, a popular shellfish-derived supplement often

title: Made in China
text: During the 2008 Chinese export recalls, heparin was recalled by the U.S. Food and Drug Administration (FDA) due to contamination of the raw heparin stock imported from China. Lenovo has admitted in a public statement that it had pre-installed third-party adware named Superfish that was considered malicious on an unknown number of machines, beginning from 2010. In 2013, Chinese Premier Li Keqiang and his State Council approved a plan called "Made in China 2025". Drafted by the Ministry of Industry and Information Technology, it took over two years to complete by one hundred and fifty people. The plan's aim is

title: 2008 Chinese heparin adulteration
text: fraction of true heparin starting material, and mimics the in-vitro properties of heparin, the counterfeit was almost certainly intentional as opposed to an accidental lapse in manufacturing. The raw heparin batches were found to have been cut from 2–60% with the counterfeit substance, and motivation for the adulteration was attributed to a combination of cost effectiveness and a shortage of suitable pigs in China. When the FDA conducted an inspection of Baxter's Chinese Heparin supplier, it found serious deficiencies at the facility which the FDA detailed in a warning letter. This example once again demonstrated the consequences of a company

title: 2008 Chinese heparin adulteration
text: not following basic Good Manufacturing Practices (GMPs). As detailed in the Warning Letter, the company failed to monitor changes in the impurity profile of incoming heparin active raw material, adequately investigate out-of-specification results, document actual processing steps in batch records, validate all critical steps in the process, qualify all suppliers, and use valid methods to test products. The FDA has stated that it does not have the funds nor bear the responsibility to inspect on a regular basis overseas upstream processors of finished active pharmaceutical ingredients such as heparin. However, according to the internationally harmonized guideline, ICH Q7, API manufacturers

title: Baxter International
text: was brought into question when they were linked to 19 deaths in the United States. Upon inspection, one of the raw ingredients used by Baxter was found to be contaminated – between 5 and 20 percent – with a substance that was similar, but not identical, to the ingredient itself. The company initiated a voluntary recall, temporarily suspended the manufacture of heparin, and launched an investigation. The investigation into the contamination has focused on raw heparin produced by Changzhou Scientific Protein Laboratories, a China-based branch of Scientific Protein Laboratories, based in Waunakee, Wisconsin. Due to procedural errors, Changzhou SPL's facilities

title: Baxter International
text: were never subjected to inspection by US FDA officials, as required by FDA regulations. In addition, Changzhou SPL's products were also never certified as safe for use in pharmaceutical products by Chinese FDA officials, due to Changzhou SPL's registration as a chemical company rather than a pharmaceutical manufacturer. Though Baxter was first to recall heparin because of increased adverse reactions, after the contaminant was identified and testing protocols were shared with other manufacturers globally, over a dozen other companies in nearly a dozen countries issued recalls, which linked back to certain supply points in China. In early 2009, samples of

title: Heparin
text: abnormality is not associated with liver dysfunction, and it disappears after the drug is discontinued. The other complication is hyperkalemia, which occurs in 5 to 10% of patients receiving heparin, and is the result of heparin-induced aldosterone suppression. The hyperkalemia can appear within a few days after the onset of heparin therapy. More rarely, the side-effects alopecia and osteoporosis can occur with chronic use. As with many drugs, overdoses of heparin can be fatal. In September 2006, heparin received worldwide publicity when three prematurely born infants died after they were mistakenly given overdoses of heparin at an Indianapolis hospital. Heparin

title: Heparin
text: used for arthritis, which was intended to substitute for actual heparin in potency tests. According to the New York Times: 'Problems with heparin reported to the agency include difficulty breathing, nausea, vomiting, excessive sweating and rapidly falling blood pressure that in some cases led to life-threatening shock'. In 2006, Petr Zelenka, a nurse in the Czech Republic, deliberately administered large doses to patients, killing 7, and attempting to kill 10 others. In 2007, a nurse at Cedars-Sinai Medical Center mistakenly gave the 12-day-old twins of actor Dennis Quaid a dose of heparin that was 1,000 times the recommended dose for

title: Heparin
text: is contraindicated in those with risk of bleeding (especially in people with uncontrolled blood pressure, liver disease, and stroke), severe liver disease, or severe hypertension. Protamine sulfate has been given to counteract the anticoagulant effect of heparin (1 mg per 100 units of heparin that had been given over the past four hours). It may be used in those who overdose on heparin or to reverse heparin's effect when it is no longer needed. Heparin's normal role in the body is unclear. Heparin is usually stored within the secretory granules of mast cells and released only into the vasculature at

title: Heparin
text: hospital pharmacy and was unrelated to the product's packaging or labeling. , the exact cause of the twins' death was under investigation. In March 2010, a two-year-old transplant patient from Texas was given a lethal dose of heparin at the University of Nebraska Medical Center. The exact circumstances surrounding her death are still under investigation. Pharmaceutical-grade heparin is derived from mucosal tissues of slaughtered meat animals such as porcine (pig) intestines or bovine (cattle) lungs. Advances to produce heparin synthetically have been made in 2003 and 2008. In 2011, a chemoenzymatic process of synthesizing low molecular weight heparins from simple

title: Heparin-induced thrombocytopenia
text: United Kingdom, and danaparoid is not available in the United States. Fondaparinux, a Factor Xa inhibitor, is commonly used off label for HIT treatment in the United States. According to a systematic review, people with HIT treated with lepirudin showed a relative risk reduction of clinical outcome (death, amputation, etc.) to be 0.52 and 0.42 when compared to patient controls. In addition, people treated with argatroban for HIT showed a relative risk reduction of the above clinical outcomes to be 0.20 and 0.18. Lepirudin production stopped on May 31, 2012. Up to 8% of patients receiving heparin are at risk

title: Royal Canin
text: in the area of research and development. A dedicated research centre was opened in Saint-Nolff, Brittany, during 1973. Over the ten years up to 1982 additional subsidiaries were also set up in other European countries. These included Italy, Sweden, Belgium, Spain, Germany and Denmark. Another factory was built in northern France to service sales in the countries of the north of Europe. The Guyomarc'h group of companies was purchased by the Paribas Bank in 1990. Royal Canin recorded a loss in 1993; the following year the Guyomarc'h group was divided into four separate businesses, one of which remained as Royal

title: Dicoumarol
text: wet sweet-clover hay, as the cause of a naturally occurring bleeding disease in cattle. See warfarin for a more detailed discovery history. Identified in 1940, dicoumarol became the prototype of the 4-hydroxycoumarin anticoagulant drug class. Dicoumarol itself, for a short time, was employed as a medicinal anticoagulant drug, but since the mid-1950s has been replaced by its simpler derivative warfarin, and other 4-hydroxycoumarin drugs. It is given orally, and it acts within two days. Dicoumarol was used, along with heparin, for the treatment of deep venous thrombosis. Unlike heparin, this class of drugs may be used for months or years.

title: Guizhentang Pharmaceutical Company
text: the practice of TCM, said that heparin is also extracted from intestines of pigs and ox's lungs, and the manufacturers are listed on the stock exchange. Phoenix Television have pointed out a quote from Karl Marx where he said for a profit margin of 300% in a capitalist system, one will commit any crime. Guizhentang has achieved this maximized margin per bear for years. The company also openly calls their bile juice a "name brand" in the market. Guizhentang do not breed the most bears, as there are 10 other companies in the country that breed more in Heilongjiang and

title: Gewiss–Ballan
text: indicating doping. These figures would later be published in L’Equipe (discussed below). In addition the documentary told of how during the Tour of Denmark on August 4, 1995, journalists made a doping find in a hotel room where the soigneur of Gewiss Paolo Ganzerli had slept the night before. Six riders of the team had also stayed in the hotel on that night of August 3, 1995. The journalists found a Gewiss bag filled with 12 used and bloodied needles, an ampule which according to its label contained Recomon 5000 (EPO) and three blank ampules of which subsequent tests revealed

title: Discovery and development of direct Xa inhibitors
text: from a canine liver, which in Greek translates to hepar. Heparin targets multiple factors in the blood coagulation cascade, one of them being FXa. At first, it had many side effects but for the next twenty years, investigators worked on heparin to make it better and safer. It entered clinical trials in 1935 and the first drug was launched in 1936. Chains of natural heparin can vary from 5.000 to 40.000 Daltons. In the 1980s Low molecular weight heparin (LMWH) were developed and they only contain chains with an average molecular weight of less than 8.000 Da. In the 1920s

title: Heparin
text: function. Heparin appears to be relatively safe for use during pregnancy and breastfeeding. Heparin is a naturally occurring glycosaminoglycan. The discovery of heparin was announced in 1916. It is on the World Health Organization's List of Essential Medicines, the most effective and safe medicines needed in a health system. The wholesale cost in the developing world, when used for prevention, is about US$9.63–37.95 per month. In the United States it costs about $25–50 per month. A fractionated version of heparin, known as low molecular weight heparin, is also available. Heparin is a naturally occurring anticoagulant produced by basophils and mast