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  • recall
  • An Illinois-based dog food company has expanded its recall due to concerns of possible contamination by a drug that is used for euthanasia. (foxnews.com)
  • Ranbaxy had initiated a voluntary recall of its generic atorvastatin drug after it was informed by one of its suppliers that there could be a possibility that the drug could have been contaminated by glass materials. (medindia.net)
  • Last week, Rugby Laboratories issued a voluntary nationwide recall of all lots of two liquid docusate sodium laxatives, Diocto Liquid and Diocto Syrup, made by PharmaTech due to possible Burkholderia cepacia contamination. (raps.org)
  • A drug recall removes a prescription or over-the-counter drug from the market. (wikipedia.org)
  • When a drug recall is made, the drug is removed from the market and potential legal action can be taken depending on the severity of the drug recall. (wikipedia.org)
  • This graph charts the rise in drug recalls by class in the United States from 2004 to 2014 with data from Regulatory Affairs Professionals Society The recall process in the United States follows three approximate phases. (wikipedia.org)
  • A firm submitting a recall to the FDA must provide all relevant information about the specific drug, including but not limited to: product name, use, description, and at least two samples of product (including packaging, instructions, inserts, etc. (wikipedia.org)
  • Microorganisms
  • The severity of the effects that microorganisms may have on any particular drug product is a function of the nature of the product, its intended use, and the nature of the microorganism concerned. (scribd.com)
  • In either situation, or in any related situation, the presence of microorganisms ought to be avoided in drug products . (scribd.com)
  • The authors cultured microorganisms, if present, from the 0.2-µm filter unit and from the residual contents of the syringes used for drawing up or administering drugs. (asahq.org)
  • The authors collected used syringes at the end of each case and grew microorganisms from residual drug in 55 of these 2,318 (2.4%) syringes including all the aforementioned microorganisms and also Kocuria kristinae , Staphylococcus aureus , and Staphylococcus hominus . (asahq.org)
  • Microorganisms with the potential to cause infection are being injected (presumably inadvertently) into some patients during the administration of intravenous drugs by bolus during anesthesia. (asahq.org)
  • cepacia
  • On Aug. 8, 2017, the FDA advised health care professionals and patients not to use any liquid drug products manufactured by PharmaTech, following CDC's laboratory testing of PharmaTech's oral liquid docusate detected a strain of B. cepacia linked to recent patient infections. (drugs.com)
  • In 2016, the FDA advised health care professionals and patients not to use liquid docusate drug products manufactured at PharmaTech's Davie, Florida, facility after the products were implicated in CDC's public health investigation into a multistate outbreak of B. cepacia infections. (drugs.com)
  • sterile
  • The FDA is advising healthcare professionals and consumers against the use of drugs marketed as sterile by Downing Labs LLC, also known as NuVision Pharmacy in Dallas, TX, as they may be contaminated. (empr.com)
  • The FDA inspected NuVision and observed insanitary conditions that result in a lack of sterility assurance of purportedly sterile drug products produced by the company. (empr.com)
  • The inspection revealed sterility failures in 19 lots of drug products intended to be sterile, endotoxin failures in three lots of drug products, and inadequate or no investigation of these failures. (empr.com)
  • Administration of non-sterile drug products intended to be sterile may result in serious and potentially life-threatening infections or death. (empr.com)
  • Healthcare professionals should immediately check their medical supplies, quarantine any sterile drug products from NuVision, and not administer them to patients. (empr.com)
  • residues
  • That research follows a 2003 study in northern Texas, where every bluegill, black crappie and channel catfish researchers caught living downstream of a wastewater treatment plant tested positive for the active ingredients in two widely used antidepressants - one of the first times the residues of such drugs were detected in wildlife. (sbsun.com)
  • food
  • Nanowerk News ) Following the U.S. Food and Drug Administration's recent decision to participate in the inspection of overseas drug-manufacturing facilities, the pharmaceutical industry is reexamining its approach to quality control. (nanowerk.com)
  • GLENVIEW, Ill. - Mead Johnson Nutrition over the holidays conducted a new round of testing on samples of a batch of Enfamil Premium Newborn powdered formula related to a Food and Drug Administration investigation. (drugstorenews.com)
  • While there have been no reports of any harm caused to its users, the US Food and Drug Administration revealed that Ranbaxy had informed that it will be ceasing the production of the drug until its investigation is complete. (medindia.net)
  • The US Food and Drug Administration (FDA) has set up a dedicated webpage where it details an elevated cancer risk from this contamination. (chemistryworld.com)
  • What's less well-known is that each year, hundreds of new inventions are produced in the laboratories of NIH, the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA), and these inventions are licensed out to private companies in the US and internationally for further research and development, with the hopes of bringing new products to market. (raps.org)
  • The US Food and Drug Administration (FDA) on Friday issued draft guidance detailing a risk-based framework for drugs and biologics containing nanomaterials or made using nanotechnology. (raps.org)
  • The US Food and Drug Administration (FDA) on Monday released new draft guidance outlining how it will take a new risk-based enforcement approach to drug products labeled as homeopathic. (raps.org)
  • In the United States, current Good Manufacturing Practice (cGMP) regulations are issued by the U.S. Food and Drug Administration (FDA) as the minimum requirements for quality systems for FDA-regulated products such as food, drugs, biologics and devices. (scribd.com)
  • This legislation will allow (U.S. Food and Drug Administration) to require higher standards for certain drugs and better protect the public health. (blogspot.com)
  • Compounders will have the opportunity to register as outsourcing facilities subject to oversight by the U.S. Food and Drug Administration in much the same way as traditional manufacturers are monitored. (blogspot.com)
  • This food processor replaced his aeromechanical conveyors with the Hapman Series "C" Tubular Drag Conveyors. (hapman.com)
  • Nery claimed he had failed the drug test due to food contamination. (wikipedia.org)
  • In August, 2004 the US Food and Drug Administration (USFDA) determined zinc-DTPA and calcium-DTPA to be safe and effective for treatment of those who have breathed in or otherwise been contaminated internally by plutonium, americium, or curium. (wikipedia.org)
  • In the United States, it is regulated by the U.S. Food and Drug Administration (FDA), and may only be lawfully distributed by order of a licensed veterinarian. (wikipedia.org)
  • In September 2012, the Centers for Disease Control and Prevention, in collaboration with state and local health departments and the Food and Drug Administration (FDA), began investigating a multistate outbreak of fungal meningitis and other infections among patients who had received contaminated steroid injections from the New England Compounding Center (NECC) in Framingham, Massachusetts. (wikipedia.org)
  • On November 14, 2012, members of a congressional committee investigating the outbreak accused the Food and Drug Administration (FDA) of failing to prevent the crisis by moving too slowly against the Massachusetts pharmacy. (wikipedia.org)
  • Furthermore, many officials and government departments, namely, the U.S. Food and Drug Administration, have fallen victim to regulatory capture. (wikipedia.org)
  • The book goes on to state that the Pure Food and Drug Act of 1906 is not effective in arresting these trends, and real reform or consumer protection is obstructed by the powerful connections that offending corporations have with the government. (wikipedia.org)
  • The book argues that many products would not be sold if properly labeled, and this failure to police product labeling has been a key failing of the Food and Drug Administration. (wikipedia.org)
  • Extensive reform and overhaul in government regulation and inspection of the food and drug industry is needed in order to adequately protect consumers from corporations and manufacturers who do not place the health of the consumer before profit. (wikipedia.org)
  • Currently, the only drug approved by the Food and Drug Administration to treat radionuclide contamination is diethylenetriaminepentaacetic acid (DTPA) (Figure 1). (wikipedia.org)
  • Drug quality is primarily controlled by the National Agency for Food and Drug Administration and Control (NAFDAC). (wikipedia.org)
  • purity
  • ASPEX is a leading provider of integrated solutions for a wide range of critical cleanliness, microcontamination analysis, product purity, contamination diagnostics, predictive maintenance, and other process control initiatives incorporating scanning electron microscopes and elemental analysis technologies. (nanowerk.com)
  • Finally, in a separate study, Abergel evaluated the purity of this molecule for potential drug applications, ultimately bringing this effort closer to the development of a deployable treatment solution. (wikipedia.org)
  • News
  • Rather than take off for Christmas, the editors of Drug Store News took a look at the year ahead and the stories, issues and trends that will make headlines in retail pharmacy in 2012. (drugstorenews.com)
  • According to Drug Store News blogger Moira Koch, those retailers engaging m-commerce with e-coupons and daily deals will reap the benefits with increased loyalty and traction. (drugstorenews.com)
  • batches
  • Following a spate of recalls earlier in the year , many more batches of valsartan and related blood pressure drugs are being recalled after carcinogenic impurities have been found beyond the Chinese manufacturer they had been thought to originate from. (chemistryworld.com)
  • For example, if the firm finds a leaking pipe near a product assembly line and tests for batches of the drug produced on that line are positive for contamination, they would submit that as the reason to how they believe their products came to be affected. (wikipedia.org)
  • possible
  • Elsewhere in the world - from the icy streams of England to the wild game reserves of South Africa - snails, fish, even antelope, are showing signs of possible pharmaceutical contamination. (sbsun.com)
  • On October 9, 2012, members of the United States Congress asked federal health officials for briefings on the outbreak as a first step toward possible legislative action to strengthen federal drug safety regulations. (wikipedia.org)
  • Laboratory
  • No drug-lab contamination was found at the laboratory site and a member of the DOE's Hazardous Spill Response Team asserted that high barium levels on the property were unlikely to be the result of Riconosciuto's work. (wikipedia.org)
  • product
  • Today, we are taking a critical step forward in securing the safety of our drug supply chain by creating a product tracing system and improving the quality of compounded drugs, which unfortunately have operated in the past under a faulty law," Pallone said. (blogspot.com)
  • First, the cables were continually fraying and breaking - putting small metallic fragments into their product, which caused a tremendous amount of product contamination and rejection. (hapman.com)
  • Drugs and medical devices are typically recalled if the product is defective, contaminated, contains a foreign object, fails to meet specifications, mislabeled, or misbranded. (wikipedia.org)
  • counterfeit
  • Because counterfeit or contaminated drugs can result in allergic reactions or even death (as evidenced by the widely-publicized heparin epidemic), the Rx's ability to identify harmful particles as small as 30 nanometers yields far-reaching effects for consumer safety. (nanowerk.com)
  • There is currently no system for tracking the drugs that make up some four billion prescriptions per year in the U.S. which means drugs that are stolen or counterfeit may not be discovered before reaching consumers, Pallone said. (blogspot.com)
  • recalls
  • Drug recalls in the United States are made by the FDA or the creators of the drug when certain criteria are met. (wikipedia.org)
  • Drug recalls are classified in the US by the FDA in three different categories. (wikipedia.org)
  • Class II recalls refer to drugs that induce temporary and/or medically reversible health effects. (wikipedia.org)
  • A more comprehensive list of drug recalls worldwide can be found here: List of withdrawn drugs. (wikipedia.org)
  • Drug recalls can be initiated by the producing firm or the FDA, and those launched by the FDA can be either mandatory or voluntary. (wikipedia.org)
  • Health
  • Summer pointed out Colorado is the only state in the nation that has a law giving health care providers immunity from civil liability if they tell other hospitals about an employee's past "drug diversion, drug tampering, patient abuse, violation of drug or alcohol policies of the employer, or crimes of violence. (kdvr.com)
  • Erin Fox, director of drug information the University of Utah Health Care told Focus that this lack of information makes it difficult to respond to such advisories. (raps.org)
  • A new U.S. Congressional bill that would help ensure the safety of compounded drugs and the nation's pharmaceutical supply chain deserves support, said U.S. Rep. Frank J. Pallone Jr., D-N.J., the top Democrat on the House Energy and Commerce Health Subcommittee. (blogspot.com)
  • After that time has elapsed both calcium-DTPA and zinc-DTPA are similarly effective in reducing internal contamination with plutonium, americium or curium, and zinc-DTPA is less likely to deplete the body's normal levels of zinc and other metals essential to health. (wikipedia.org)
  • In Sweden, the industry together with universities and health care sector has developed a method for environmental risk assessment and environmental classification of drugs. (wikipedia.org)
  • investigation
  • In October 2012, an investigation of the NECC revealed the company had been in violation of its state license because it had been functioning as a drug manufacturer, producing drugs for broad use rather than filling individual prescriptions. (wikipedia.org)
  • antibiotics
  • A prospective, open, microbiological audit of 303 cases in which anesthesiologists were asked to inject all bolus drugs, except propofol and antibiotics, through a 0.2-µm filter was performed. (asahq.org)
  • 3204
  • Pallone co-authored the bipartisan Drug Quality and Security Act or H.R. 3204, which was developed partly in response to last year's meningitis outbreak in Massachusetts caused by contaminated compounded drugs mixed at the New England Compounding Center, which killed 64 people and sickened 750 more, said Pallone in a release. (blogspot.com)
  • manufacturer
  • Current federal regulations require that a drug be labeled with the name and place of business of the manufacturer, packager or distributor. (raps.org)
  • The bill also would create a uniform framework for tracking drugs from the manufacturer to the pharmacy. (blogspot.com)
  • manufacture
  • The regulation was also meant to limit the manufacture and import of fake or sub-standard drugs and to curtail false advertising. (wikipedia.org)
  • result
  • ENGLEWOOD, Colo. -- Swedish Medical Center has been served with a class-action lawsuit filed by three former patients as a result of a drug contamination scandal . (kdvr.com)
  • source
  • It was uncovered in the Sacramento Bee that while the initial source of the contamination comes from money used in the Illegal drug trade in circulation, the U.S. Federal Reserve unwittingly spreads the substance to clean currency by mixing the notes together. (wikipedia.org)
  • internal
  • The recommended treatment is for an initial dose of calcium-DTPA, as this salt of DTPA has been shown to be more effective in the first 24 hours after internal contamination by plutonium, americium, or curium. (wikipedia.org)
  • usually
  • Each time he was let go because of drug use, usually for acquiring Fentanyl illegally at his workplace. (kdvr.com)