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  • 8
    May
    2013
    3:51pm, EDT

    FDA inspection triggers recall by Fla. compounding pharmacy

    By Matthew Perrone 
    AP

    The Food and Drug Administration warned doctors and pharmacists Wednesday to avoid drugs made by a Florida specialty pharmacy called The Compounding Shop, due to potential safety problems uncovered by health inspectors. 

    The St. Petersburg, Fla.-based pharmacy has agreed to recall all of its sterile drugs and is in the process of notifying customers, the FDA said in a statement. The agency said health care professionals should quarantine drugs from the company and not administer them to patients.

    The Compounding Shop is a compounding pharmacy, which means it mixes custom formulations of drugs to meet doctors' specifications. In recent weeks the FDA has cracked down on compounding pharmacies across the country, triggering several national recalls.

    The wave of inspections comes in the wake of a nationwide fungal meningitis outbreak last year tied to contaminated drugs from a Massachusetts pharmacy. The outbreak has killed 55 people and made 741 Americans sick with either fungal meningitis or infections at the site where they were injected.

    The FDA said a recent inspection of The Compounding Shop raised concerns about sterility problems with company drugs that could lead to bacterial contamination. 

    "If an injectable drug product that is intended to be sterile is contaminated, it could result in a life-threatening infection in patients," said Janet Woodcock, director of FDA's drug center, in a statement.

    Patients who received products form the pharmacy and have concerns should contact their doctor. 

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  • 19
    Apr
    2013
    6:26pm, EDT

    Natura expands pet food recall on salmonella risk

    Associated Press
    Natura Pet Products is expanding a recall of dry pet foods over a possible salmonella risk to animals and people. 

    The company, a unit of Procter & Gamble Co., first announced a voluntary recall in March of its dog, cat and ferret foods because they may be contaminated with salmonella bacteria. The company's recall now includes all dry pet food products and treats with expiration dates prior to and including March 24, 2014.

    Salmonella can affect animals that eat contaminated products and there is a risk to people who handle contaminated pet products, especially if they have not thoroughly washed their hands after exposure.

    Pets with salmonella infections may be lethargic and have diarrhea or bloody diarrhea, fever and vomiting. Some pets will have only decreased appetite, fever and abdominal pain. Infected but otherwise healthy pets can be carriers and infect other animals or humans.

    The company recommended that , that consumers contact a veterinarian, if a pet has consumed the recalled product and has those symptoms.

    Humans infected with salmonella may suffer nausea, vomiting, diarrhea or bloody diarrhea, as well as abdominal cramps and fever.

    Natura said there have been no confirmed reports of illness tied to the product, but it is actively investigating consumer complaints.
    The company said testing confirmed salmonella in some dry pet food and cat treats, but it decided to also recall product made around the same time out of an abundance of caution.

    The recall includes dry pet foods and treats only; no canned wet food or biscuits are involved. The products were sold through veterinary clinics and certain pet specialty stores in the U.S., Canada, Hong Kong, Korea, Japan, Malaysia, Singapore, Australia and Costa Rica, as well as online. 

    A complete list of the recalled foods is available online at http://www.naturapet.com . Customers should throw away affected pet foods. More information is available from Natura at (800) 224-6123.

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  • 29
    Mar
    2013
    2:54pm, EDT

    Mini quesadillas, pizza slices recalled over E. coli fears

    BUFFALO, N.Y. - Rich Products Corp. has announced a voluntary recall of 192,222 pounds of its Farm Rich Mini Quesadillas and other Farm Rich products because of a possible E. coli contamination.

    The recall of also includes the Buffalo, N.Y.-based company's Farm Rich Mini Pizza Slices, Farm Rich Philly Cheese Steaks, Farm Rich Mozzarella Bites and Market Day Mozzarella Bites. They were produced Nov. 12 through Nov. 19.

    The Farm Rich products were distributed in retail stores nationwide. The company says it's working with the Food Safety Inspection Service in the U.S. Department of Agriculture to identify the possible contamination source.

    The problem came to light after one person became ill and food samples were tested. Twenty four cases have now been reported in 15 states, the USDA said in a statement.

    E. coli 0121, the strain implicated in the outbreak, is one of six known as non-0157 Shiga toxin-producing E. coli that were banned in 2011 from the U.S. meat supply.  Testing for the six began last spring, a move that was opposed by the meat industry.

    Like E. coli O157:H7, the six new strains are capable of producing bloody diarrheal illness that can lead to kidney failure and death. In 2010, for the first time, the non-O157 strains, were responsible for more infections in the U.S. than E. coli O157:H7, according to federal health officials.

    Consumers with questions about the recall can call 1-888-220-5955.

    The Associated Press and NBC News contributed to this report.

    Related stories:

    Six new E. coli strains banned from beef supply

    Testing for new E. coli strains in beef finally to begin

     

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  • 25
    Mar
    2013
    2:52pm, EDT

    Inspection yields another compound pharmacy recall

    By Tim McLaughlin, Reuters

    BOSTON - The crackdown on specialty pharmacies that compound drugs into customized doses on Monday yielded another recall after an inspection by the Food and Drug Administration.

    Pallimed Solutions Pharmacy, which specializes in treating erectile dysfunction, said it issued a voluntary recall of 16 sterile compound products, including injectable testosterone. Pallimed of Woburn, Massachusetts, also said it agreed to stop all sterile compounding activities.

    "The company took this aggressive precautionary recall measure on the basis of information observed during the course of an inspection conducted by the Food and Drug Administration and the Massachusetts Board of Registration in Pharmacy," Pallimed said in a statement. The recall is limited to sterile compounded products dispensed on or after January 1.

    Authorities are coming to grips with how to oversee compounding pharmacies in the wake of a deadly meningitis outbreak that has killed 50 and injured more than 700 people.

    FDA Commissioner Margaret Hamburg said in an official blog post on Friday that serious problems continue to take place at compounding pharmacies and she is hopeful that the Senate committee with jurisdiction over the issue "will yield strong legislation for patients across the nation."

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  • 25
    Mar
    2013
    12:51pm, EDT

    2 million blood glucose meters recalled worldwide

    By Bill Berkrot, Reuters

    Johnson & Johnson is recalling and replacing more than 2 million meters used to measure blood glucose levels in diabetics due to a failure to operate properly at extremely high glucose readings, the company's LifeScan unit said on Monday.

    In the United States, about 90,000 OneTouch Verio IQ meters are affected out of some 1.2 million units of that model being recalled worldwide, the company said.

    At extremely high glucose readings of 1024 mg/dl and above, the units have failed to provide a warning of dangerously high blood sugar and will shut off, potentially delaying proper treatment, the company said.

    LifeScan said it has notified the U.S. Food and Drug Administration and other health regulators of the voluntary recall, as well as registered users and healthcare professionals.

    In addition to the Verio IQ model, J&J is also recalling about 670,000 of its OneTouch Verio Pro meters in Europe and 4,900 of its hospital-based OneTouch Verio Pro+ meters in the Middle East, Europe and the Asia/Pacific region.

    No patient injuries have been reported in the United States related to the malfunction, the company said. LifeScan said there was one report of a serious adverse event outside the United States, but a link to the malfunctioning glucose meter had not been determined.

    "We regret the inconvenience these actions may cause. However, we will always err on the side of caution and make a decision that is in the best interest of our patients," Michael Pfeifer, LifeScan's chief medical officer, said in a statement.

    The company said its OneTouch Ultra model was not affected by the recall.

    It said patients could continue to use the Verio IQ model until replacements arrive as long as they are aware that if the unit shuts down it could be indicative of dangerously high glucose levels.

    Related:

    High-glycemic foods tied to diabetes risk

    Copyright 2013 Thomson Reuters. Click for restrictions.

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  • 21
    Mar
    2013
    12:56pm, EDT

    Georgia pharmacy expands recall after eye infections

    By Maggie Fox, Senior Writer, NBC News

    A Georgia compounding pharmacy that recalled eye injections earlier this week because of possible contamination is recalling everything it made now.

    The Food and Drug Administration says Clinical Specialties of Augusta, Ga., is voluntarily recalling all lots of all sterile products it repackaged and distributed because it cannot assure they are sterile. The agency has cracked down on compounding pharmacies after an outbreak of fungal meningitis and other fungal infections that has affected 722 people and killed 50.

    “This expanded recall follows the firm’s initial recall of Avastin on March 18, 2013, due to reports of five patients who have been diagnosed with serious eye infections associated with the use of the product,” the FDA said in a statement.

    “The Centers for Disease Control and Prevention (CDC) notified the FDA of these endophthalmitis infections, which occur inside the eyeball. Endophthalmitis after intravitreal injection is a serious complication that can lead to permanent loss of vision. Clinical Specialties Compounding sterile products covered under this recall were distributed nationwide between October 19, 2012 and March 19, 2013.”

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    The firm was repackaging the cancer drug Avastin for use in treating a degenerative eye condition called macular degeneration. The drug has been shown to help stop progression of the disease.

    The drug company Roche, which makes Avastin, makes a version called Lucentis specifically for use in the eye. But Lucentis costs as much as $2,000 per dose, compared to $150 a dose for Avastin when reformulated by a compounding  pharmacist. Roche has complained that repackaging Avastin in this way can lead to contamination and infections.

    The FDA says Clinical Specialties isn’t able to ensure that its practices are keeping its products sterile. Inspections at the New England Compounding Center, which caused the fungal meningitis outbreak, showed widespread contamination and poor hygiene.

    “Until further notice, health care providers should stop using all sterile products distributed by Clinical Specialties Compounding and return them to the company,” the FDA says.

    Related:

    • Eye infections prompt Avastin recall
    • Nurse spotted mold-tainted drugs right away, hospital says
    • Visible mold forces recall of N.J. pharmacy injection drugs
    • FDA warns of new batch of fake cancer drug Avastin

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  • 21
    Mar
    2013
    10:06am, EDT

    FDA: 'Male enhancement' products deliver more than you bargained for

    By Maggie Fox, Senior Writer, NBC News

    Three “male enhancement” products being sold online say they’re all herbal, but they contain hidden prescription drug ingredients and could be dangerous, the Food and Drug Administration said on Thursday.

    The three contain compounds similar to the active ingredients in the erectile dysfunction drugs Viagra and Cialis, the FDA said. They can cause serious problems in men being treated for heart disease and should not be taken without a doctor’s supervision.

    The names of the three products -- “Rock-It Man”, “Libido Sexual Enhancer” and “Stiff Days” -- leave little doubt what they are supposed to be used for. But while they are marketed as alternatives to the prescription drugs to be used without the guidance of a doctor, they are in fact virtual copies, without any oversight to ensure they are safe.

    “FDA laboratory analysis confirmed that ‘Rock-It Man’ contains the undeclared ingredient hydroxythiohomosildenafil.  Hydroxythiohomosildenafil is structurally similar to sildenafil, the active ingredient in Viagra, an FDA-approved prescription drug for Erectile Dysfunction (ED),” the FDA says in a statement.

    “This undeclared ingredient may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels. Men with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.”

    Testing confirmed similar findings in “Libido Sexual Enhancer” and “Stiff Days".

    Anyone who has bought any of the products should just toss them, the FDA advises.

    “Consumers who have experienced any negative side effects should consult a health care professional as soon as possible,” it adds.

    “This notification is to inform the public of a growing trend of dietary supplements or conventional foods with hidden drugs and chemicals.  These products are typically promoted for sexual enhancement, weight loss, and body building, and are often represented as being ‘all natural.’  FDA is unable to test and identify all products marketed as dietary supplements on the market that have potentially harmful hidden ingredients.”

    Related:

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    Men can get bone disease, too -- but most don't know it

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  • 19
    Mar
    2013
    6:04pm, EDT

    5 eye infections prompt Avastin injection recall

    By JoNel Aleccia, Senior Writer, NBC News

    A Georgia compounding pharmacy is recalling 40 lots of Avastin injection syringes after reports that at least five patients developed eye infections from off-label use of the drug.

    The injection drugs -- typically used as a less-expensive way to treat wet age-related macular degeneration -- were distributed starting Dec. 18, 2012 to doctors’ offices in Georgia, Louisiana, South Carolina and Indiana by Clinical Specialties Inc. of Augusta, Ga.  Austin Gore, the pharmacist who runs the firm, said all five infections appeared to be linked to a single Georgia pharmacy, but Georgia health officials said one of those infections actually occurred in Indiana. Indiana health officials said the situation was under investigation.

    The patients have developed bacterial endophthalmitis caused by streptococcus bacteria, said Cherie Dreznek, Georgia's state epidemiologist. Food and Drug Administration officials warned health care workers in August 2011 about the dangers of using repackaged eye injections of Avastin, a cancer drug known generically as bevacizumab.

    At least a dozen people developed eye infections, the FDA said, including some who were blinded after receiving the tainted injections. Another four patients developed eye infections in Tennessee, state officials said at the time.

    Clinical Specialties has notified doctors’ offices of the recall and urged health workers to immediately stop using the Avastin injections.

    Made by the firm Genentech, Avastin solution for IV injection is approved to treat various cancers. It frequently is used off-label to treat macular degeneration because Avastin costs about $50 per injection while Lucentis, the Genentech drug approved for injection, costs about $2,000 per injection.

    Consumers should contact Clinical Specialties at 866-880-1915 if they have experienced any eye problems after an injection of Avastin distributed by the firm.

    Related stories: 

    • Nurse spotted mold-tainted drugs right away, hospital says
    • Visible mold forces recall of N.J. pharmacy injection drugs
    • FDA warns of new batch of fake cancer drug Avastin 

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  • 7
    Mar
    2013
    11:16am, EST

    Bumble Bee recalling tuna cans over loose seals

    By The Associated Press

    Bumble Bee Foods LLC is recalling some of its 5-ounce canned tuna because of a risk the fish could spoil.

    The company said Wednesday that some cans' seals may not be tight enough. Loose seals could let in pathogens and spoil the tuna, sickening an eater.

    There have been no reports so far of any related illnesses.

    The cans were distributed to retailers across the country between Jan. 17 and Feb. 28 and have "best by" rates that range from Jan. 16, 2016 through Jan. 18, 2016.

    The products subject to the recall include Bumble Bee brand and Brunswick brand 5-ounce cans of chunk white albacore in water and chunk light tuna in water and vegetable oil.

    Consumers who think they may have purchased one of the recalled products can contact Bumble Bee to get their money back and throw away the canned tuna.

    Bumble Bee is privately held and based in San Diego.

    © 2013 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

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  • 11
    Feb
    2013
    2:24pm, EST

    Glass fragments in Lean Cuisine spur recall

    By MyHealthNewsDaily Staff

    Some packages of Lean Cuisine ravioli, made by Nestlé, are being recalled because they may contain fragments of glass, the Food and Drug Administration said today.

    The recall applies only to packages of Lean Cuisine Culinary Collection Mushroom Mezzaluna Ravioli, with the production codes 2311587812 or 2312587812, and the "best before by" date of December 2013, the FDA said.

    Nestlé voluntarily issued the recall after three customers reported they had found glass in the ravioli. None of the customers reported injuries, the FDA said.

    The recalled packages were made in November 2012, and Nestlé believes that few remain on store shelves, but could still be in customers' freezers at home.

    Customers who have purchased the recalled product should not eat it, and should contact Nestlé. Read the FDA release for full details.

    More from MyHealthNewsDaily:

    • 8 Top Meals from Nutritionists
    • 5 Reasons Not to Fear Getting Older
    • 13 Kitchen Changes that Can Help You Lose Weight 

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  • 23
    Nov
    2012
    6:21pm, EST

    Cholesterol-lowering generic Lipitor recalled for glass particles

    By NBC News services

    Indian drugmaker Ranbaxy Laboratories Ltd has recalled its generic version of Pfizer Inc.'s cholesterol-lowering drug Lipitor in the United States after certain batches were found to contain glass particles.

    Ranbaxy's U.S. subsidiary, Ranbaxy Pharmaceuticals Inc, said the recall affects certain lots of 10-, 20- and 40-milligram doses of the drug, known generically as atorvastatin calcium. The 80-milligram dosage is not affected.

    The company is conducting an investigation which it expects will take two weeks. It did not report any injuries connected to the tainted pills and did not say how the problem was discovered. 

     It's the latest in a series of problems, dating to 2006, involving manufacturing deficiencies at multiple Ranbaxy factories and alleged doctoring of test results on some medicines. U.S. regulators had banned imports of 30 Ranbaxy medicines and wouldn't approve any new products for sale until Ranbaxy agreed to make improvements and be monitored by a third party for five years.

    "Given its dominant share of this high-volume drug, we are certain to see supply shortages over the next two weeks," said Ross Muken, an analyst at ISI Group LLC.  The near-term impact is likely to be felt most by retail pharmacies and more modestly by wholesalers, he added.

    The recall is the latest in a series of manufacturing problems at Ranbaxy, which is operating under heightened scrutiny following a long-running dispute with the U.S. Food and Drug Administration.

    In 2008 the FDA banned the company from importing about 30 drugs after it found manufacturing deficiencies at two of the company's facilities in India. In 2009 the U.S. government accused Ranbaxy of falsifying data used in drug applications.

    Last December, Ranbaxy agreed to make changes to its manufacturing plants in the United States and India. And it said it would set aside $500 million to resolve any potential civil or criminal charges stemming from an investigation by the U.S. Department of Justice.

    Under a proposed settlement earlier this year, Ranbaxy agreed to engage a third party to conduct a review of its facilities, implement procedures to ensure data integrity in its marketing applications, and ensure it meets good manufacturing practices.

    During its first six months on the market, when it enjoyed marketing exclusivity, atorvastatin generated sales of nearly $600 million for Ranbaxy, according to Bhagwan Singh Chaudhary, a research associate at the brokerage IndiaNivesh.

    "The (recall) will impact the company's credibility," said Chaudhary. "A recall suggests corrective measures suggested by the U.S. FDA are not being implemented."

    Other drugmakers, including Indian rival Dr. Reddy's Laboratories Ltd, have launched their own versions of Lipitor, and the market has become more competitive.

    In 2008, Japan's Daiichi Sankyo Co acquired a majority stake in Ranbaxy in a deal valued at $4.2 billion.

    Reuters and The Associated Press contributed to this report

    More health news from NBCNews.com:

    Rapid action needed to stop malaria in Greece 

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    US abortions drop 5 percent, biggest decline in a decade

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  • 18
    Oct
    2012
    6:46pm, EDT

    Smucker's Uncrustables sold to schools recalled

    By Steve Karnowski
    AP

    Officials have told school lunch programs across the country to check to see whether they have any Smucker's Uncrustables sandwiches that might contain peanut butter made by a New Mexico company that is being recalled because of potential salmonella contamination.

    The J.M. Smucker Co. used peanut butter that was produced by Sunland Inc. and supplied by the U.S. Department of Agriculture in "limited production runs" of 72-count bulk packs of the sandwiches that went to schools under the National School Lunch Program, Smucker's spokeswoman Maribeth Badertscher said in an email Thursday.

    Related post: Peanut plant closed after feds find more salmonella

    Uncrustables are pre-made peanut butter and jelly, pocket-like, circular sandwiches.

    The Orrville, Ohio-based company tests all the incoming USDA-supplied peanut butter it gets, and tests finished products before distributing them, and found no problems, she said.

    But out of "an abundance of caution," and working with federal agencies, she said, Smucker's recently notified school customers that they should check to see if they still have any of the crustless frozen peanut butter and jelly sandwiches from the recalled lots, which all have either expired or will expire soon. They should not be served to students, the company said.

    No other Smucker's products contain peanut butter from Sunland or other outside suppliers, Badertscher said. She said she did not immediately know how many sandwiches were involved.

    Related post: Peanut butter plant tests positive for salmonella; recall widens

    Sunland shut down its plant in Portales, N.M., last month and recalled more than 200 products made under a variety of brand names after salmonella was found in Trader Joe's Creamy Salted Valencia Peanut Butter. Thirty-five illnesses in 19 states have been linked to Sunland, but no illnesses have been linked to the Uncrustable sandwiches.

    "When USDA learned of the FDA recall of certain products manufactured by Sunland, Inc., we coordinated with state agencies to immediately notify individual school districts and ensure that recalled products were identified and destroyed," USDA spokeswoman Alyn Kiel said in an email.

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JoNel Aleccia is an award-winning national health reporter at NBC News. She has spent more than 25 years covering health, food safety, education and social issues for newspaper and online readers.

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