Marllory Dadiana Chacon Rossell leads a drug trafficking and money laundering organization based out of Guatemala with operations in Honduras and Panama that supplies the Mexican drug cartels.  Chacon Rossell is believed to be one of the most prolific narcotics traffickers in Central America.  She is responsible for transshipping thousands of kilograms of cocaine per month through Guatemala, into Mexico, and on to the United States.  Chacon Rossell is also believed to launder tens of millions of U.S. dollars in narcotics proceeds each month, making her the most active money launderer in Guatemala.

“Marllory Chacon’s drug trafficking activities and her ties to the Mexican drug cartels make her a critical figure in the narcotics trade,” said OFAC Director Adam J. Szubin.  “By designating Chacon, OFAC is disrupting those activities and closing off from the U.S. financial system the network of companies aiding Chacon’s illicit activities.”

OFAC is also designating Jorge Andres Fernandez Carbajal, Chacon’s husband, a Honduran citizen responsible for providing logistical support for his wife’s organization.  Hayron Eduardo Borrayo Lasmibat and Mirza Silvana Hernandez De Borrayo, both Guatemalan nationals, are also being designated today for providing support to Marllory Chacon’s drug trafficking activities.   OFAC is also designating two Guatemalan companies, Bingoton Millonario and Revoluciones Por Minuto Aceleracion S.A., which are owned, controlled, or directed by Mirza Silvana Hernandez de Borrayo and Hayron Eduardo Borrayo Lasmibat, and two Panamanian companies, Andrea Yari S.A. and Fer’Seg S.A, which are owned, controlled, or directed by Jorge Andres Fernandez Carbajal.

OFAC coordinated on this investigation with the Drug Enforcement Administration.  Today’s action is part of ongoing efforts pursuant to the Kingpin Act to apply financial measures against significant foreign narcotics traffickers and their organizations worldwide. The Treasury Department has designated more than 1,000 individuals and entities pursuant to the Kingpin Act since June 2000.

Penalties for violations of the Kingpin Act range from civil penalties of up to $1.075 million per violation to more severe criminal penalties. Criminal penalties for corporate officers may include up to 30 years in prison and fines up to $5 million. Criminal fines for corporations may reach $10 million. Other individuals face up to 10 years in prison and fines pursuant to Title 18 of the United States Code for criminal violations of the Kingpin Act.

The FDA announced a Consent Decree of permanent injunction filed March 2, 2009, enjoining KV Pharmaceutical Company, its subsidiaries ETHEX Corporation and Ther-Rx Corporation, and its principal officers from making and distributing adulterated and unapproved drugs. The injunction against KV and the other defendants, once entered by the court, will prevent them from manufacturing and shipping drugs until the firm obtains FDA approval. It will remain in place until the defendants sustain continuous compliance with FDA’s current Good Manufacturing Practice (cGMP) and new drug approval requirements for six years.

The Consent Decree also enjoins KV’s officers David A. Van Vliet, president and chief executive officer; Rita E. Bleser, president of the pharmaceutical division; Jay S. Sawardeker, vice president of corporate quality, and Marc S. Hermelin, former chief executive officer and a member of KV’s Board of Directors, from manufacturing and distributing any drug at or from KV’s facilities until the company’s procedures and products are brought into compliance with the law.

KV Pharmaceutical manufactures, processes, packages, labels, holds, and distributes drugs from various locations in St. Louis, Mo., and the surrounding area. FDA inspected KV between December 2008 and February 2009, and found that the company had significant cGMP violations and continued to manufacture unapproved drugs. As a result of those inspections, which led to this action, KV recalled all products manufactured and distributed from its facilities.

“The FDA requires companies to manufacture drugs in accordance with the current good manufacturing practice standards and to comply with FDA approval requirements,” said Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research (CDER). “Consumers need to be confident that drugs meet our manufacturing requirements for identity, strength, purity, and quality, and have been evaluated by the FDA for safety and efficacy.”

Under the terms of the Consent Decree, the defendants cannot resume manufacturing and distributing drugs until both an independent expert and FDA officials conduct inspections of their facilities and certify that they are in compliance with the Federal Food, Drug, and Cosmetic Act (the Act), its implementing regulations, and the decree. The Consent Decree also requires the defendants to destroy all drugs they recalled between May 2008 and Feb. 3, 2009. Those drugs are currently in their possession.

If the defendants fail to comply with any provision of the Consent Decree, the Act, or FDA regulations, FDA may order the firm to again stop manufacturing and distributing drugs, recall the products, or take other corrective actions.

“The FDA will carefully monitor the provisions of this injunction against the KV Pharmaceutical Company to ensure compliance,” said Michael Chappell, the acting associate commissioner of FDA’s Office of Regulatory Affairs. “Companies should know that FDA will investigate and take action against other marketers of unapproved drugs.”

The Consent Decree subjects the defendants to liquidated damages of $15,000 per day if they fail to comply with any of the provisions of the decree, and the payment of an additional $15,000 for each violation, up to $5 million per year.

A shutdown of the Novartis facility that manufactures Endo oral pain medications was announced today by both Endo and the Food and Drug Administration (FDA). The action was prompted by rare reports that one or more doses of the wrong medication were found in bottles or unit-dose packages, as well as packaging problem noted by FDA during a mid-December inspection. Affected products include oxymorphone, oxycodone with acetaminophen or aspirin, morphine extended release and hydrocodone with acetaminophen.

A recall was not initiated based on the high potential for serious shortages with disruption in care and the low risk of receiving mixed-up products. Endo has warned that short-term supply disruptions may occur. FDA issued a public health advisory this morning that includes guidance for patients and the healthcare community.

This recall affects ONLY Part Number 03-2695-9 and ONLY Part Number 03-2795-7. To locate the specific lot numbers, see the
Firm Press Release.

These products were manufactured between June 11, 2010 and October 17, 2010. Part Number 03-2695-9 was distributed between August 2010 and November 2010. Part Number 03-2795-7 was distributed between August 2009 and November 2010.

The CombiSet Hemodialysis Blood Tubing Set is blood tubing used during hemodialysis. It is intended for single use only. The CombiSet Hemodialysis Blood Tubing Set may be used with conventional and high flux negative pressure hemodialyzer equipment.
The hemodialysis blood tubing sets may develop kinking of the arterial line. Kinking can cause the destruction of red blood cells which may result in serious injury and/or death.

Public Contact: Clinic Managers, Unit Administrators, and/or distributors with questions may contact the Fresenius Medical Care Customer Service Team at 1-800-323-5188 (within the U.S.).

The FDA stated …

“On November 19, 2010, the company sent their customers an “Urgent Recall” letter by certified mail with return receipt. Customers were instructed to check their stock immediately to determine if they had any of the affected lots. If they did, customers were instructed to IMMEDIATELY discontinue using the affected lots and place the products in a secure and separate area for return to the company. Customers were instructed to contact the company for instructions on how to return the recalled products.”

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

E. coli 0157:H7 causes diarrhea illness often with bloody stools. Although most healthy adults can recover completely within a week, some people can develop a form of kidney failure. Young children and the elderly are most susceptible to serious complications and even death. Consumers should seek immediate medical care if they develop these symptoms.

All of the following Sally Jackson cheese products are included in this recall:

• Cow’s milk cheese
• Goat’s milk cheese
• Sheep’s milk cheese
• Cow’s milk cheese wrapped in chestnut leaves
• Sheep’s milk cheese wrapped in chestnut leaves
• Goat’s milk cheese wrapped in grape leaves

Signage is posted in Whole Foods Market stores to notify customers of this recall.

Customers who have purchased any of the listed products from Whole Foods Market may return them to the store for a full refund.

Consumers with questions may contact Whole Foods Market at 512-542-0878 weekdays between 8:00am and 5:00pm central standard time.

The FDA sought market withdrawal of propoxyphene after receiving new clinical data showing that the drug puts patients at risk of potentially serious or even fatal heart rhythm abnormalities. As a result of these data, combined with other information, including new epidemiological data, the agency concluded that the risks of the medication outweigh the benefits.

“The FDA is pleased by Xanodyne’s decision to voluntarily remove its products from the U.S. market,”

said John Jenkins, M.D., director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research (CDER).

“These new heart data significantly alter propoxyphene’s risk-benefit profile. The drug’s effectiveness in reducing pain is no longer enough to outweigh the drug’s serious potential heart risks.”

The FDA is advising health care professionals to stop prescribing propoxyphene to their patients, and patients who are currently taking the drug should contact their health care professional as soon as possible to discuss switching to another pain management therapy.

Propoxyphene is an opioid used to treat mild to moderate pain. First approved by the FDA in 1957, propoxyphene is sold by prescription under various names both alone (e.g., Darvon) or in combination with acetaminophen (e.g., Darvocet).

Since 1978, the FDA has received two requests to remove propoxyphene from the market. Until now, the FDA had concluded that the benefits of propoxyphene for pain relief at recommended doses outweighed the safety risks of the drug.

In January 2009, the FDA held an advisory committee meeting to address the efficacy and safety of propoxyphene. After considering the data submitted with the original drug applications for propoxyphene, as well as subsequent medical literature and postmarketing safety databases, the committee voted 14 to 12 against the continued marketing of propoxyphene products. In making this recommendation, the committee noted that additional information about the drug’s cardiac effects would be relevant in weighing its risks and benefits.

In June 2009, the European Medicines Agency (EMEA) recommended that the marketing authorizations for propoxyphene be withdrawn across the European Union. A phased withdrawal of propoxyphene is underway.

In July 2009, the FDA decided to permit continued marketing, but required that a new boxed warning be added to the drug label alerting patients and health care professionals to the risk of a fatal overdose. In addition, the agency required Xanodyne to conduct a new safety study assessing unanswered questions about the effects of propoxyphene on the heart.

The agency now has reviewed the data from that study, which show that, even when taken at recommended doses, propoxyphene causes significant changes to the electrical activity of the heart. These changes, which can be seen on an electrocardiogram (ECG), can increase the risk for serious abnormal heart rhythms that have been linked to serious adverse effects, including sudden death. The available data also indicate that the risk of adverse events for any particular patient (even patients who have taken the drug for many years) is subject to change based on small changes in the health status of the patient, such as dehydration, a change in medications, or decreased kidney function.

“With the new study results, for the first time we now have data showing that the standard therapeutic dose of propoxyphene can be harmful to the heart,”

said Gerald Dal Pan, M.D., M.H.S., director of the Office of Surveillance and Epidemiology, CDER.

“However, long-time users of the drug need to know that these changes to the heart’s electrical activity are not cumulative. Once patients stop taking propoxyphene, the risk will go away.”

In recent years, FDA has alerted consumers to nearly 300 tainted products marketed as dietary supplements and received numerous complaints of injury associated with these products.

The FDA’s letter emphasizes that manufacturers and distributors are responsible for ensuring that their products comply with the law. Five major trade associations – Council for Responsible Nutrition, Natural Products Association, United Natural Products Alliance, Consumer Healthcare Products Association and American Herbal Products Association– are joining FDA on a call for media and have agreed to share the letter widely within the industry.

“These tainted products can cause serious adverse effects, including strokes, organ failure, and death,” said FDA Commissioner Margaret A. Hamburg, M.D. “The manufacturers selling these tainted products are operating outside the law.“

The FDA is seeking input and collaboration from dietary supplement trade associations to educate the industry about this problem and to help develop new strategies to combat it, according to Hamburg. The agency also announced a new RSS feed to warn consumers more quickly about tainted products marketed as dietary supplements.

The FDA has noted the three most common categories of these illegal products:

• Weight loss products containing active ingredients such as sibutramine: Sibutramine is the active ingredient in the drug Merida, which was recently withdrawn from the market due to increased risk of heart attack and stroke. The FDA has discovered dozens of products, such as Slimming Beauty, Solo Slim, Slim-30, and others, which contain sibutramine or closely related drugs (analogs).
• Body-building products containing anabolic steroids or steroid analogs: These products can cause acute liver injury and increase the risk for heart attack, stroke and death. Products like Tren Xtreme, ArimaDex, and Clomed have been labeled to contain either anabolic steroids or aromatase inhibitors, which prevent anabolic steroids from being converted to estrogen.
• Sexual enhancement products that contain the same active ingredient or an analog of the active ingredient in the approved drugs Viagra, Cialis, and Levitra. The approved products are available only by prescription, and they should not be used by people who have certain medical conditions, such as cardiovascular disease. Products determined to be in violation of federal law by the FDA include Vigor-25, Duro Extend Capsules for Men, Magic Power Coffee, and others.

“The labeling of these tainted products may claim that they are ‘alternatives’ to FDA-approved drugs, or ‘legal’ alternatives to anabolic steroids,”

said Michael Levy, director of the Division of New Drugs and Labeling Compliance at the FDA’s Center for Drug Evaluation and Research.

“Consumers should avoid products marketed as supplements that claim to have effects similar to prescription drugs. Consumers should also be wary of products with labeling only in a foreign language or that are marketed through mass e-mails.“

Companies that make or distribute tainted products may receive warning letters and/or face enforcement actions such as product seizures, injunctions, and criminal prosecution. Responsible individuals may also face criminal prosecution.

Lawful dietary supplements contain minerals, vitamins or other dietary ingredients and are intended to be an addition to a standard diet. The FDA regulates these products under the Dietary Supplement Health and Education Act, passed by Congress in 1994.

Unlike drugs, dietary supplements do not have to be approved by the FDA prior to marketing. Dietary supplement manufacturers and distributors are responsible for selling a safe product. FDA’s Current Good Manufacturing Practices require dietary supplement manufacturers to have proper manufacturing and quality assurance controls in place to ensure the quality of their products, including controls to prevent the inclusion of contaminants that could adulterate their products.

Source: HematologyLibrary.org

This product may be contaminated with Clostridium botulinum spores, which can cause Botulism, a serious and potentially fatal food borne illness. Symptoms of botulism include blurred vision, general weakness and poor reflexes, difficulty in swallowing and respiratory paralysis.

The sale of un-eviscerated fish is prohibited under New York State Agriculture and Markets regulations because Clostridium botulinum spores are more likely to be concentrated in the viscera than any other portion of the fish. Un-eviscerated fish has been linked to outbreaks of botulism poisoning.

The recalled dried fish Vobla gutted comes in a coded, plastic vacuum packed bag with the following code: Production date: 21.06.2010, lot # 280610140 and is a product of Germany. This product was sold nationwide.

The U.S. Food and Drug Administration recently took action against companies that manufacture, distribute, and/or market unapproved single-ingredient oral colchicine, a medication commonly used for the daily prevention of gout, to treat acute gout flare-ups, and for the treatment of Familial Mediterranean Fever (FMF).

The companies are expected to stop manufacturing single-ingredient oral colchicine within 45 days and must stop shipping this unapproved product in interstate commerce within 90 days. A small amount of unapproved colchicine is expected to be available after these dates until supplies are exhausted.

Many single ingredient oral colchicine products have been used by the medical community for decades. These and a variety of other medications have not received the mandatory modern-day FDA-approval required of all prescription drugs.

Colcrys is the only FDA-approved single-ingredient oral colchicine product available on the U.S. market.

The manufacturer of Colcrys, Mutual Pharmaceutical/URL Pharma, has established a Patient Assistance Program (PAP) and a Co-Pay Assistance Program (CAP) to ensure that all patients will be able to continue affordable access to colchicine. The company also has informed FDA that it will maintain the programs at a minimum until there is FDA-approved generic competition for Colcrys. The PAP covers three groups of people: those with insurance; those without insurance; and Medicare beneficiaries enrolled in Part D who do not want the cost of Colcrys to contribute toward their true out-of-pocket expenditures under Part D. The CAP helps eligible patients reduce their Colcrys prescription co-pay to no more than $25 per prescription.

The FDA’s recent action is part of the their broader initiative against marketed unapproved drugs, announced in a June 2006 Compliance Policy Guide describing the agency’s risk-based enforcement approach for marketed unapproved drug products.

“The need for drugs to go through the FDA approval process is clearly demonstrated by our review of oral colchicine tablets,”

said Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research (CDER).

“Without our safety review and proper drug labeling, the old standard of care would likely have continued, to the detriment of patients.”

Unapproved versions of colchicine are not generic drugs. Generic drugs are approved by the FDA to assure that the approved generic drug products meet the same standards as the innovator drug. All single-ingredient oral colchicine products, other than Colcrys, that are currently being marketed are unapproved drugs and have never been evaluated by the agency.

“It is a priority for the FDA to get unapproved medications, such as older versions of single ingredient oral colchicine, either updated to conform to FDA’s current approval standards or off the market,”

said Deborah M. Autor, director of CDER’s Office of Compliance.

“The FDA remains committed to ensuring that prescription drugs have the necessary FDA approval. We encourage companies to actively pursue approval or face the type of action announced today.”

The FDA previously took action against unapproved colchicine for injection products on Feb. 6, 2008. This ongoing initiative is designed to bring all unapproved medications, including single-ingredient oral colchicine, up to modern-day safety, efficacy, labeling, and quality standards by ensuring that they comply with FDA approval requirements. The FDA is committed to working with companies to ensure that marketed drugs are safe and effective, and meet appropriate standards for manufacturing and labeling.