Despite FDA Warning, Sports Supplements Still Available Online: Study

DMAA sports supplements have been linked to at least two deaths and the U.S. Food and Drug Administration sent warning letters to 10 manufacturers last spring about a lack of data on their safety, but a new study finds these supplements can still be purchased online.

DMAA (dimethylamylamine) is a pre-workout supplement used by athletes to build muscle. Some research suggests that it may narrow blood vessels, which can elevate blood pressure, and may set the stage for a heart attack. Canada and the U.K have banned DMAA from all supplements.

Now, a small study published online Dec. 3 in the Archives of Internal Medicine reports that all 16 of the products mentioned in the FDA’s warning letters are still available through online retailers.
It’s good to know that the FDA is right on top of enforcement.

From the Journal:
The stimulant DMAA, also known as 1,3-dimethylamylamine, has been the subject of much controversy.¹ In the United States, it is currently marketed as a dietary supplement, primarily in products promoted as a preworkout supplement for boosting strength, energy, and power. Two of the most prominent supplements containing DMAA are “Jack3d” and “OxyELITE Pro” (USP Labs) However, there are over 250 commercial dietary supplements containing DMAA on the market.²
http://health.usnews.com/health-news/news/articles/2012/12/03/despite-fda-warning-sports-supplements-still-available-online-study

Do Valium, Ativan, Xanax, Klonopin and Restoril Increase Pneumonia Risk?

ome studies have shown that benzodiazepine sedatives — including such drugs as Valium, Ativan, Xanax, Klonopin and Restoril — may increase susceptibility to infection. Might this risk extend to pneumonia?

THIS STUDY analyzed data on 34,661 people of all ages, including 5,895 who took benzodiazepines and 4,964 who developed pneumonia. People who took benzodiazepines were 54 percent more likely to have later contracted pneumonia than those who did not take the sedating drugs. Chances of dying were also greater among those who took benzodiazepines: 22 percent higher within 30 days of contracting pneumonia and 32 percent higher within about three years.

WHO MAY BE AFFECTED? People who take benzodiazepines. Commonly prescribed for anxiety and insomnia, the drugs are also used to relieve muscle spasticity, prevent seizures, calm agitation, sedate patients before surgery and ease alcohol withdrawal.

 http://www.washingtonpost.com/national/health-science/popular-sedatives-may-raise-risk-for-pneumonia-a-study-says/2012/12/10/57c01042-6a25-11e1-acc6-32fefc7ccd67_story.html

Does Alli Cause Liver and Kidney Damage?

Orlistat, which goes by the prescription brand name Xenical and the over-the-counter name Alli, can cause “severe toxicity” to major internal organs, says a recent study. .

The research results obtained by pharmacology professor Bingfan Yan were worrying enough that he immediately reported the results to the FDA, which approved orlistat in 1999.

Liver and kidney damage are serious enough, but the report had another finding that orlistat’s metabolic action reduces the effectiveness of many medications, including life-saving cancer treatments. In fact, the researchers reported that cancer cells multiplied faster under the influence of orlistat. Orlistat also boosts the anti-clotting effects of aspirin, raising the risk of bleeding both internal and external.


 http://www.sciencedaily.com/releases/2012/12/121210145234.htm?utm_source=feedburner&utm_medium=feed&utm_campaign=Feed%3A+sciencedaily+%28ScienceDaily%3A+Latest+Science+News%29&utm_content=Google+Feedfetcher

http://www.forbes.com/sites/melaniehaiken/2012/12/10/popular-weight-loss-drug-may-cause-liver-failure/

December 7, 2012: NECC Tainted Steroid Medication Update

Our firm filed a Motion to Inspect the NECC facility. The FDA issued an inspection report, and in it there are observations of the New England Compounding Facility. A number of issues will be part of the litigation, including the "Clean Room" where the recalled products were made.  

Here's a virtual clean room, put together by Purdue:





Generally found in hospitals and home health care companies, the rooms are used to prepare drugs, intravenous drips, syringes, chemotherapy treatments and the like, especially those administered directly into the bloodstream—a factor that makes vital the use of a clean room and proper clean-room procedures. Concern over the rise of antibiotic-resistant pathogens has only increased the need for such expertise.

Why this matters in the New England  Compounding Pharmacy litigation: Access, production, and preparation all will be analyzed to determine if this tragedy could have been prevented if the clean room was operated the right way. 

Talk to our law firm if you were harmed by a medication made by NECC. 

Recall Notification of Life Pulse High-Frequency Ventilator Patient Circuits

Bunnell Incorporated will voluntarily initiate a nationwide recall notification of Life Pulse High-Frequency Ventilator Patient Circuits. A complete list of Lot numbers affected by the recall is identified in the recall notice and on Bunnell’s website,  www.bunl.com.

The product has been found to have heater wire insulation that can melt, causing sparking and smoke close to the humidifier cartridge.  There have been 12 reported failures out of 5,771 Patient Circuits distributed.  There have been no reports of patient injury or death.  However, out of an abundance of caution Bunnell wants clinicians to be aware of the potential that a Patient Circuit failure could result in patient injury or death.

Bunnell is working with the U.S. Food and Drug Administration to resolve this issue.

Bunnell will notify customers via certified mail and will post the recall notification and other important information at www.bunl.com.

http://www.fda.gov/Safety/Recalls/ucm330842.htm

FDA vegetarian meat recall: Veggie Patch – The Ultimate and Falafel

News from the FDA on this recall:

EGGIE PATCH® is voluntarily recalling two products --The Ultimate Meatless Burger and Falafel-- due to a risk of contamination with Listeria monocytogenes.  Listeria monocytogenes is an organism that can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.  Although healthy persons may suffer only short-term symptoms such as high fever, severe headaches, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths in pregnant women.

The Ultimate Meatless Burger and Falafel, from VEGGIE PATCH, with the specific use-by dates and UPC codes listed below were distributed to a select number of retailers and distributors.

• 9-ounce trays of refrigerated, fully cooked, VEGGIE PATCH, The Ultimate Meatless Burger with a Use-By date, Jan/12/2013; UPC code 6-10129-00211-5 (which can be found on back of package)
• 9-ounce trays of refrigerated, fully cooked, VEGGIE PATCH, Falafel with a Use-By date, Jan/15/2013; UPC code 6-10129-06619-3 (which can be found on back of package)

The Ultimate Meatless Burger potentially affected was available for sale as of November 21, 2012, in the following states; NY, CT, PA, FL, IL, MD, IN, WI, VA, NJ and DE.  Falafel potentially affected, was available for sale as of November 21, 2012, nationwide.
No illnesses have been reported to date.  VEGGIE PATCH discovered this issue as part of its routine testing of its products.

Consumers who purchased any product with the specific use-by dates and UPC codes listed above are asked to dispose of the product. They should email contactus@veggiepatch.com to arrange for a full refund.  The recall affects only these two items. Products that do not contain the specific use-by dates and UPC codes listed are not affected by the recall.  No other VEGGIE PATCH products or other use-by dates of The Ultimate Meatless Burger or Falafel are affected by this recall.  Frozen Veggie Patch products are not affected by this recall.

Do NFL Players use Viagra to Enhance Performance?

NFL  wide receiver Brandon Marshall says he's heard of some NFL players using the drug to improve athletic performance — on the field. One benefit of Viagara and similar drugs would be the enhanced delivery of oxygen to the muscles, which also aids in hastening the body's recovery from workouts. The drug also counteracts impotence, a frequent side-effect of steroid usage.



http://msn.foxsports.com/nfl/story/nfl-players-viagra-brandon-marshall-performance-enhancing-drug-112912

November 30, 2012 Meningitis Recall News Update

The Framingham pharmacy linked to the fungal meningitis outbreak blamed for the deaths of dozens of pain sufferers has been told by a federal judge not to tamper with or attempt to destroy anything within the company’s walls — or even stored on personal cellphones and home computers.

My office is lead counsel on the Green v. NECC case, and there were hearings held in that case this past week. We sought for preservation of evidence and asked for permission to inspect the facilities where the recalled products were compounded. 

U.S. District Court Judge F. Dennis Saylor IV today told lawyers for  New England Compounding Center and its sister operation Ameridose he intends to issue an evidence-preservation order on behalf of 12 civil suits pending against one or both of the pharmacies in Boston’s federal court alone.

At a hearing this, Saylor also temporarily consolidated the 12 lawsuits for the convenience of pre-trial discovery and proceedings. Saylor is juggling just a handful of the 70 cases that have been filed federally against NECC and Ameridose nationwide, and which he noted may all be brought under one umbrella here or in another district early next year.

http://www.bostonherald.com/news/regional/view.bg?articleid=1061178004&srvc=rss

FDA Issues Warning Letter to Mushroom Supplements Company

Here's the warning letter to this company:

The products are labeled for conditions that cause them to be drugs. Also the dietary supplements have been prepared, packed, or held under conditions that do not meet the CGMP in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements regulation. Although the firm sent out samples of finished product lots to outside laboratories for testing, the laboratories only tested for heavy metals (mercury, lead, arsenic, and cadmium) and food chemistry (ash, total calories, total carbohydrates, fat, moisture, and protein); instead of conducting assay tests to determine that the components were consistent with your firm’s established specifications, etc. (Amyloban 3399 From Lion’s Mane, Grifron Maitake, and Super Shiitake); FDCA 505(a), 21 CFR 111.75, 111.560(a)(2), 111.325(b)(1), 111.535(b)(2), 111.160(d)(1), 111.160(c)(3), 111.35(b)(4).
 
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm325553.htm

Warnings of suffocation risk from infant sleep positioners

A new report however from the Centers for Disease Control and Prevention finds the products have caused 13 suffocation deaths in young infants since 1997.  Unintentional suffocation is the leading cause of injury death for U.S. children younger than 1-year-old, according to the CDC.

For the CDC's report, researchers reviewed information collected by the U.S. Food and Drug Administration (FDA) and the U.S. Consumer Product Safety Commission (CPSC) between 1997 and 2011 on the natures of deaths associated with infant sleep positioners. The devices aim to keep a baby in a specific position while sleeping.

Read more here. 

US regulators report possible link between 5 Hour Energy & deaths

 The U.S. Food and Drug Administration confirmed on Wednesday the receipt of reports that another caffeine drink, 5-hour Energy, may have been involved in a number of deaths - in this case 13 over the past four years.

The reports were first detailed by the New York Times on Wednesday.

The news follows the FDA's disclosure last month that it was investigating reports of five deaths that may be related to Monster Beverage's namesake drinks.

The highly caffeinated beverages are the fastest-growing type of soft drink in the United States, with sales increasing 17 percent last year to about $9 billion, according to Beverage Digest.

FDA spokeswoman Shelly Burgess said that 5-hour Energy, sold by Living Essentials, has been mentioned in some 90 FDA filings since 2009, including more than 30 that involved serious or life-threatening events likeheart attacks, convulsions, and in one case, a spontaneous abortion, the New York Times reported.

The Times said another federal agency, the Substance Abuse and Mental Health Services Administration, reported late last year that more than 13,000 emergency room visits in 2009 were associated with energy drinks alone.

But Elaine Lutz, spokeswoman for Living Essentials, the company that distributes 5-hour Energy, said in a statement that the product "is not an energy drink" (the so-called shot comes in a bottle that holds less than 2 ounces).

http://www.baltimoresun.com/health/sns-rt-us-usa-energydrink-deathsbre8ae07a-20121114,0,4904784.story
"Living Essentials," the statement went on, "takes reports of any potential adverse event tied to our products very seriously. We fully comply with all of our reporting requirements." The company was "unaware of any deaths proven to have been caused by the consumption of 5-hour Energy."

Nesquik Recall

Nestlé USA announced the voluntary recall of limited quantities of Nestlé NESQUIK® Chocolate Powder in the 10.9, 21.8 and 40.7 ounce canisters. The voluntary recall is limited to only NESQUIK Chocolate Powder, which was distributed nationally. No other varieties of NESQUIK powder or any sizes or flavors of NESQUIK ready-to-drink are affected by this recall.

Nestlé is removing the canisters from distribution because the company was notified by an ingredient supplier, Omya Inc. that it has issued a recall of certain lots of its ingredient, calcium carbonate due to possible presence of Salmonella. Calcium carbonate is used in NESQUIK as an ingredient. There have been no reports of any illnesses or adverse health effects associated with the affected product.

To ensure the safety of consumers, Nestlé is recalling selected NESQUIK Chocolate Powder. The recall is limited to the following sizes, UPC and production codes of NESQUIK Chocolate Powder:

Size	UPC Code	Production Codes
40.7 oz. Chocolate (72 servings)	0 28000 68230 9	2282574810 2282574820
21.8 oz. Chocolate (38 servings)	0 28000 68090 9	2278574810 2278574820 2279574810 2279574820 2284574820 2284574830 2285574810 2285574820 2287574820 2289574810 2289574820
10.9 oz. Chocolate (19 servings)	0 28000 67990 3	2278574810

The affected NESQUIK Chocolate Powder was produced during early October, 2012. To locate the production code, consumers should look on the bottom of the canister, adjacent to the consumer expiration date. All affected products have an expiration date of BEST BEFORE Oct 2014.

Consumers who may have purchased the affected NESQUIK Chocolate Powder should not consume it, but instead should return it to the place of purchase for a full refund or contact Nestlé Consumer Services at (800) 628-7679.

The most common symptoms of Salmonella infection are diarrhea, abdominal cramps and fever, which develop within eight to 72 hours of eating or drinking contaminated food. The illness usually lasts for four to seven days and most people recover without treatment. However, salmonellosis can be severe or even life threatening for infants, older people, pregnant women and those with weakened immune systems. Individuals experiencing these symptoms should seek medical attention.

FDA: Ameridose Recalls All Products

From Reuters:

Ameridose, a sister company of the pharmacy linked to a meningitis outbreak that has killed 28 people, announced Wednesday a voluntary recall of all its products, a move to cooperate with regulators that could nevertheless create shortages of some drugs.

In particular, the Food and Drug Administration is concerned about the availability of several drugs given as shots or intravenous drips or used during surgery.

The Westborough, Massachusetts-based company said it had not received any reports of adverse reactions to the products it is recalling but that the U.S. Food and Drug Administration has asked it to improve its sterility testing processes.http://www.reuters.com/article/2012/10/31/us-usa-health-meningitis-ameridose-idUSBRE89U18I20121031

The U.S. Food and Drug Administration announced today that Ameridose, LLC, based in Westborough, Mass., is voluntarily recalling all of its unexpired products in circulation. Products from Ameridose can be identified by markings that indicate Ameridose by name or by its company logo . A complete list of all products subject to this recall can be accessed at www.ameridose.com . 

The FDA is currently conducting an inspection of Ameridose’s facility. Although this inspection is ongoing, the FDA’s preliminary findings have raised concerns about a lack of sterility assurance for products produced at and distributed by this facility. Use of non-sterile injectable products can represent a serious hazard to health that could lead to life-threatening injuries. Most products produced at and distributed by this facility are represented by Ameridose to be sterile products. Ameridose entered into a voluntary agreement with the Massachusetts Board of Registration in Pharmacy to cease all pharmacy and manufacturing operations starting on Oct. 10, 2012.

This recall is not based on reports of patients with infections associated with any of Ameridose’s products, and the agency recommended this recall out of an abundance of caution. Therefore, at this time, the FDA is also recommending that health care professionals do not need to follow up with patients who received Ameridose products. Health care professionals should stop using Ameridose products at this time, and return them to the firm.

Hospitals, clinics, health care professionals, and other customers with Ameridose products on hand should contact Ameridose at 888-820-0622 to obtain instructions on how to return products to Ameridose.

“The FDA’s top priority is to ensure that drugs are safe for the American public,” said FDA Commissioner Margaret A. Hamburg, M.D.

Together with the State of Massachusetts, the FDA commenced the current inspection of the Ameridose facility as part of the agency’s ongoing fungal meningitis outbreak investigation. Ameridose is a company sharing common management by the same parties as New England Compounding Center (NECC) of Framingham, Mass., the firm associated with compounded drugs linked to the ongoing fungal meningitis outbreak.

“Because the preliminary results of the FDA’s inspection raise concerns about the sterility assurance of Ameridose’s products, the FDA is advising health care professionals to stop using all Ameridose products and follow the recall procedures provided by the firm,” explained Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research.

The FDA has identified some Ameridose products that currently appear on the critical shortage list. These products were in shortage before the Ameridose recall, but supplies may be further affected as a result of the Ameridose recall. The FDA is working with alternative manufacturers to maintain supplies of these life-saving drugs.

“The agency is taking all steps within its authority to help prevent or alleviate shortage situations and to minimize the impact this recall may have on drug supplies,” added Commissioner Hamburg.

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm326361.htm

10/30: Texas Facilities Received Tainted Steroid Meds

Texas Health Harris Methodist Hospital in Southlake has previously acknowledged receiving tainted medicine from the New England facility but says it immediately pulled the drugs and notified patients.

Other North Texas hospitals that are included on the FDA's new list as receiving other medicine from the compounding center include:

• Childrens Medical Center in Dallas. A spokesman says it treated 34 patients with amino acids not linked to any illness, and notified all of them as a precaution.
• Cook Childrens Medical Center in Fort Worth. The hospital said Wednesday that a cleanser, Glutaraldehyde, that is used to disinfect medical equipment is the only product it received from the New England Compounding Center. The hospital said it did not contact patients about the cleanser but sent the chemical back to the New England Compounding Center.
• Medical City in Dallas. The hospital immediately pulled all drugs it bought from the New England Compounding Center and is following up with patients, spokeswoman Chris Hawes said.
• Medical Center of Arlington. The hospital said it immediately pulled the medicine in question as soon as it learned of the recall but a "small number" of patients had already received doses. "While these medications have not currently been confirmed as causing infections and authorities believe the risk is very low, we are in the process of notifying these patients out of an abundance of caution," the hospital said in a statement.
• UT Southwestern Medical Center in Dallas. "UTSW had a small inventory of the topical cream, which was pulled as soon as the FDA advisory came out," the hospital said in a statement.
• Huguley Memorial Medical Center in Burleson. Pharmacy Director James Hall said it got 100 doses of a drug used to help digestion, which were all used on patients. Hall said there is no reason to believe anything was wrong with the doses but is contacting patients. "At this point, we're communicating in writing to any patient who might have received the product we bought from the NECC. ... We've quarantined a supply from a partner company Ameridose," he said. "We're waiting on steps to return it or dispose of it."
• Plaza Medical Center in Fort Worth. The hospital said none of the drugs it got from the New England Compounding Center are among those said to be contaminated. The hospital said it sent letters to patients to let them know where the drug they took came from and to tell them they are fine. Plaza Medical Center said the drugs are locked up and will not be used.

 http://www.nbcdfw.com/news/health/Voluntary-Drug-Recall-Widespread-in-North-Texas-175527951.html

Novo Nordisk Falls as FDA Panel to Discuss Insulin Risks

Novo Nordisk has reported that U.S. regulators disclosed that an advisory panel on the company’s Tresiba diabetes treatment will focus on heart risks.

http://www.bloomberg.com/news/2012-10-25/novo-falls-in-u-s-as-fda-panel-to-discuss-insulin-risk.html

Florida health department suspends compounding pharmacy

The Florida Department of Health has temporarily suspended compounding operations at a pharmacy, the latest in a growing number of closings since a deadly meningitis outbreak caused by contaminated drugs in a Massachusetts facility.

The Florida pharmacy, based in Boca Raton and called Rejuvi Pharmaceuticals, prepares injectable drugs and medications. The Florida health department said in a statement that it violated "a number" of statutes and rules.

Rejuvi Pharmaceuticals' website says it makes "bio identical hormones" and compounded medications. No other information on its products was available and Rejuvi was not immediately available for a comment.

Compounding pharmacies mix large quantities of prescription drugs, typically for use by doctors and clinics.

Regulators are scrutinizing these pharmacies after thousands of vials of contaminated injectable steroids were shipped from a New England compounding facility, leading to 25 deaths so far from fungal meningitis. Hundreds more patients were sickened from the steroid shots, which were used to treat back and neck pain.

 http://news.yahoo.com/florida-health-department-suspends-compounding-pharmacy-163904905.html

Tainted Steroid News: October 26: NECC's Inspection Report from 2011

NECC, which  made the steroid suspected in a deadly meningitis outbreak was inspected and cleared by Massachusetts inspectors last year.  The inspection by the Department of Public Health was required after the New England Compounding Center in Framingham relocated its pharmacy on the same site,

Read more: http://www1.whdh.com/news/articles/local/metro-west/12008709435973/necc-company-linked-to-outbreak-inspected-in-2011/#ixzz2ARAGHYyz


Here is the report

03 new-england-compounding-pharmacy-incnew-england-coumpouding-center-inspection-report from mzamoralaw

October 24, 2012: Tainted Steroid Recall News - List of Customers

The FDA released a comprehensive list of businesses that received products from NECC. Part one of the list is 345 pages. Here is the PDF link via Slideshare:

 

Fda list one 10 13 12 ucm325466 from mzamoralaw

Our office is investigating this national tragedy - 404-451-7781

10/22/12: Alabama Facilities Added to Tainted Steroid Medications Recipient List

The recent recall of steroid shots being linked to the deadly meningitis outbreak in the U.S. now has
Alabama clinics on alert. This morning there is news that the products may have been shipped to these facilities:


Andalusia Regional Hospital, Andalusia
Northeast Alabama Regional Medical Center, Anniston
Atmore Community Hospital, Atmore
Healthcare Authority for UAB Medical West, Bessemer
Alabama Pain Physicians, Birmingham
Baptist Medical Center-Princeton, Birmingham
Birmingham Surgery Center, Birmingham
Brookwood Medical Center, Birmingham
Children’s Hospital, Birmingham
Ginsburg Dermatology Center, Birmingham
Montclair Dermatology, Birmingham
Premier Plastic Surgery Center-AL, Birmingham
Rousso Facial Plastic Surgery, Birmingham
St. Vincent’s Hospital, Birmingham
St. Vincent’s Hospital Outpatient Surgery, Birmingham
Trinity Medical Center, Birmingham
Veterans Medical Center-GALA, Birmingham
Cullman Regional Medical Center, Cullman
Parkway Medical Center, Decatur
Dothan Surgery Center, Dothan
Flowers Hospital, Dothan
Southeast Alabama Medical Center, Dothan
Southeast Eye Clinic, Dothan
Surgery Center South, Dothan
Medical Center Enterprise, Enterprise
Gulf Health Hospital, Fairhope
South Baldwin Regional Medical Center, Foley
North Alabama Medical Center--Coffee Campus, Florence
DeKalb Regional Medical Center, Fort Payne
Gadsden Regional Medical Center, Gadsden
Marion Regional Medical Center, Hamilton
Huntsville Hospital, Huntsville
Alabama Outpatient Surgery Center, Jasper
Alabama Orthopaedic Clinic, PC, Mobile
Mobile Infirmary, Mobile
Mobile Surgery Center, Mobile
Springhill Medical Center-Cardio, Mobile
Central Alabama Pain Management Center, Montgomery
Jackson Hospital and Clinic, Montgomery
The Surgery Center, Oxford
Bigelow Cosmetic Surgery Center, Scottsboro
Vaughan Regional Medical Center, Selma
Lanier Health Services, Valley
Brookwood Dermatology, Vestavia Hills

Stryker Recalls Neptune Devices After Death Reported

Stryker stopped selling three versions of its Neptune Waste Management System after two people were harmed, one fatally, using the devices that were sold without formal clearance by U.S. regulators.

Stryker initiated a Class 1 recall, the most serious device withdrawal, on June 5 after two reports of serious injury from the products used to collect fluid waste during surgery, the Kalamazoo, Michigan-based company said today in a statement. In one instance, a patient’s passive chest drainage tube was hooked to the Neptune 2 System, a high-vacuum, high-flow device. The patient died. 

http://www.bloomberg.com/news/2012-09-25/stryker-recalls-neptune-devices-after-death-reported.html

Publix Shrimp Recalled

Here's news about a recall yesterday:

Publix Super Markets is issuing a voluntary recall for 11oz Publix Premium Frozen Tempura Shrimp. The dipping sauce packet included with the product contains soy that is not declared on the packaging. Publix discovered this during internal product evaluations.

People who have an allergy or severe sensitivity to soy run the risk of a serious or life-threatening allergic reaction if they consume products containing soy.

No illnesses have been reported to date in connection with the product.

“As part of our commitment to food safety, potentially impacted product has been removed from all store shelves,” said Maria Brous, Publix media and community relations director. “Consumers who have purchased the product in question may return it to their local store for a full refund.”

Publix customers with additional questions may call Publix’s Customer Care Center at 1-800-242-1227 or visit Publix’s website at www.publix.com  . Customers also can contact the U.S. Food and Drug Administration at 1-888-SAFEFOOD (1-888-723-3366).

Publix is privately owned and operated by its 153,500 employees, with 2011 sales of $27.0 billion. Currently Publix has 1,061 stores in Florida, Georgia, South Carolina, Alabama and Tennessee. The company has been named one of FORTUNE’s “100 Best Companies to Work For in America” for 15 consecutive years. In addition, Publix’s dedication to superior quality and customer service is recognized as tops in the grocery business, most recently by an American Customer Satisfaction Index survey. For more information, visit the company’s website, www.publix.com  .

Steroid Recall: 10 facilities in Macon, Houston County and Middle GA now on the list

Seems like you can't even wait a day before new facilities are added to the list of problem products possibly shipped from NECC. Here is today's report: 

The Food and Drug Administration is asking public health officials to contact 10 Middle Georgia health facilities to recall drugs that came from a Massachusetts company that produced contaminated steroids. But, several of those facilities say they should not be on the list.

Jennifer Jones with the North Central Health District says the FDA told the public health department to contact 10 Middle Georgia health facilities because they received products from the New England Compounding Company.

"What they received were other drugs that were compounded in the same pharmacy as the first drug that was mentioned in the news that's associated with fungal meningitis," Jones said.

Jones says the Middle Georgia facilities that received NECC products that were recalled are: Associates Surgery Center, Coliseum Same Day Surgery Center, Eye Center of Central Georgia, Forsyth Street Ambulatory Surgical Center, GA Neurosurgical Outpatient Surgery Center, Piedmont Surgery Center, Renaissance Plastic Surgery-GA, Spa Medical, Washington County Regional Medical Center, and Houston County Medical Center.

Jones says the FDA is expanding the recall "out of an abundance of caution" and says the recall is not linked with any illnesses. But at least half of the health facilities that made the list say they shouldn't be there.

The Coliseum Medical Center released the following statement:

"None of the products Coliseum Same Day Surgery Center received from NECC are currently linked to a known infection, nor were they purchased or produced by NECC after May 21, the date referenced in the FDA recommendation. We are complying with directives of the FDA."

41 NBC News received the following statement from Spa Medical in Macon:

"Spa Medical was recently listed, as a company that had ordered products from NECC.  Spa Medical did receive a recall notice which was sent to any company that may have ordered products from NECC in the past.  Spa medical did not have any of their products at the time of the recall and had never ordered any of the products recently mentioned in the media.   They have in the past ordered some topically applied products from NECC.   However, Spa Medical has never used any injectable products from NEC."

41 NBC also reached out to the other facilities and several came back saying they shouldn't be on the drug recall list. Piedmont Surgery Center sent 41 NBC a statement saying:

"Piedmont Surgery Center confirms that it has never received or administered the tainted steroid affiliated with the fungal meningitis outbreak. Our company utilizes the services of two pharmaceutical suppliers that have confirmed that they do not have any connection to the tainted product distributed by the NECC. For questions, please contact Holly Taylor at 478.405.2350."

The Renaissance Plastic Surgery says they purchased topical drugs from NECC, but those are not part of the recall. The Washington County Regional Medical Center says it hasn't received any drugs from NECC in the last six months.

http://www.41nbc.com/news/local-news/15765-fda-recalls-drugs-from-10-middle-georgia-health-facilities

Steroid Recall News: Mt. Pleasant Facility Intervene MD on the list

Here's information that a Mt. Pleasant SC facility is on the list: 

Shown as Intervene MD 843-216-4844 in that city. 

The fungus found in tainted steroid shots matches the one blamed in the national meningitis outbreak that has killed 20 people, federal health officials said Thursday.

The match confirms the link between the outbreak and the maker of the steroids, New England Compounding Center of Framingham, Mass. Officials previously said they found fungus in more than 50 unopened vials from the company, but needed more tests to determine the kind of fungus.

Read more: http://www.sfgate.com/health/article/Fungal-meningitis-steroid-tie-confirmed-3962672.php#ixzz29lEUaP9N

October 19, 2012 - Tainted Steroid Medication Update Florida, Alabama, N.C., Tennessee and other states

We received last night the updated list of facilities that may have received tainted steroid medications from New England Compounding, based in Framingham, that could put people at risking for fungal meningitis. Here's the list. Our office is investigating the company and we're seeking to hold the company accountable for hurting those infected.

As of yestrday, there are 54 cases of fungal meningitis, stroke due to presumed fungal meningitis, or other central nervous system-related infection meeting the outbreak case definition, plus 3 peripheral joint infections (e.g., knee, hip, shoulder, elbow). No deaths have been associated with peripheral joint infections.

Meningitis outbreak 10 19 list of facilities that may have received tainted steroid medications « the dietary supplement reporter from mzamoralaw

Find the list here: http://dietarysupplementreporter.wordpress.com/2012/10/19/meningitis-outbreak-1019-list-of-facilities-that-may-have-received-tainted-steroid-medications/

10/19: Alabama Meningitis Outbreak News- NECC Steroid Medications

Alabama health officials say two Alabamians are showing symptoms of meningitis after receiving tainted steroid injections. Officials have contacted four of the six additional people who also received the shot.

All six are Alabama residents who were treated in Florida, and thirteen other Alabamians were treated in Florida and Tennessee. The Alabama residents who have contracted meningitis from the contaminated drug have received the medication from outside of the state.

Now, authorities are looking at other medicines from the New England Compounding Center to see if they are safe. Health officials in both Alabama and Florida started contacting health care facilities in their states who have received such medications, but only medicines that were sent to them since January.

The clinics and physicians are being urged to then notify their patients who might have received them, especially any patients who might have been treated with injections for eye or heart surgeries.

Talk with us if you are concerned that the company that produced these products should be held accountable. Toll Free 855-525-3955

http://www.local15tv.com/news/local/story/New-Cases-New-Symptoms-of-Meningitis-in-Alabama/L46XqpNU-Uiu9EV_mF6j2g.cspx

Salad recalls in the News:

A couple of recalls make the news this week, each dealing with salad products:

1)Dole Fresh Vegetables Announces Precautionary Recall of Limited Number of Salads

Dole Fresh Vegetables is voluntarily recalling a limited number of cases of Dole American Blend salad in 12 oz. bags, coded A275208A or B, with Use-by date of October 17 and UPC 7143000933, due to a possible health risk from Listeria monocytogenes. Dole Fresh Vegetables is coordinating closely with regulatory officials. No illnesses have been reported in association with the recall. 

The product code and Use-by date are in the upper right-hand corner of the package; the UPC code is on the back of the package, below the barcode. The salads were distributed in 10 U.S. states (Illinois, Indiana, Maine, Missouri, New Jersey, New York, Ohio, Pennsylvania, Tennessee and Wisconsin). 

No illnesses have been reported in association with the recall. This precautionary recall notification is being issued due to an isolated instance in which a sample of Dole American Blend salad yielded a positive result for Listeria monocytogenes in a random sample test conducted by the Tennessee Department of Agriculture. 

No other salads are included in the recall. Only the specific Product Codes, UPC codes and October 17, 2012 Use-by date identified above are included in the recall. Consumers who have any remaining product with these Product Codes should not consume it, but rather discard it. Retailers and consumers with questions may call the Dole Food Company Consumer Response Center at (800) 356-3111, which is open 8:00 am to 3:00 pm (PT) Monday - Friday. 

http://www.foodconsumer.org/newsite/Shopping/Alerts/dole_recalls_salads_1017120653.html

2)Natural Selection Foods Recalls Earthbound Farm® Baby Spinach Grab & Go Salad® Kit 

Natural Selection Foods is voluntarily recalling Earthbound Farm Baby Spinach Grab & Go Salad Kits with Peanuts. The product is sold in a 3.5 ounce clamshell with UPC 0-32601-08875-0. All “Use By” dates are affected.

This is the result of the expanded recall of peanut butter, nut butters and peanut products by Sunland because of potential contamination with Salmonella. The peanuts in the packets were chopped by Sunland then supplied to a third party contract packer to Natural Selection Foods as a sealed package of chopped peanuts, sealed again within another package that includes dressing and a fork.

The salad kits were distributed to retail supermarkets and foodservice operators in the following states: California, Connecticut, Florida, Hawaii, Louisiana, Massachusetts, Montana, Nebraska, New Jersey, New York, Ohio, Oregon, Pennsylvania, Texas, British Columbia (Canada) and Ontario (Canada). They are packaged in clear plastic clamshell containers with a blue label.

Salmonella bacteria can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. 

Florida/USA - Steroid Recalled Medications - Facilities List

Here is the list of  of Florida facilities, and a list of facilities across the country below

• Florida Pain Clinic, Ocala, FL 
• Marion Pain Management Center, Ocala, FL 
• Orlando Center for Outpatient Surgery, Orlando, FL 
• Pain Consultants of West Florida, Pensacola, FL 
• Surgery Center of Ocala, Ocala, FL 
• Surgical Park Center, Miami, FL 

http://www.flmedical.org/New_England_Compounding_Center_Voluntary_Product_Recall.aspx

List of Healthcare Facilities which Received Lots of Methylprednisolone Acetate (PF) Recalled from NECC 
CYPRESS SURGERY CENTER DBA  559 740 4094  VISALIA  CA
ENCINO OUTPATIENT SURGICENTER  818-986-1037  ENCINO   CA
UKIAH VALLEY MEDICAL CENTER  707 463 7345  UKIAH  CA
UNIVERSAL PAIN MANAGEMENAT  661-267-6876 x166  PALMDALE  CA
INTERVENTIONAL SPINE AND SPORTS MED  203 598 7246  MIDDLEBURY  CT
FLORIDA PAIN CLINIC  352-237-5906  OCALA  FL
INTERVENTIONAL REHAB CENTER  850 484 8800  PENSACOLA  FL
MARION PAIN MANAGEMENT CENTER  352 622 1845  OCALA  FL
NORTH COUNTY SURGICENTER  561 626 6446  PALM BEACH GARDENS  FL
ORLANDO CENTER FOR OUTPATIENT SURGERY  407-426-8331  ORLANDO  FL
PAIN CONSULTANTS OF WEST FLORIDA  850 494 0000  PENSACOLA  FL
SURGERY CENTER OF OCALA  352-237-5906  OCALA  FL
SURGICAL PARK CENTER  305-271-9100 x226  MIAMI  FL
FORSYTH STREET AMBULATORY SURG. CTR.  478-749-1610  MACON  GA
PAIN SPECIALISTS OF IDAHO  208 522 7246  IDAHO FALLS  ID
WALTER KNOX MEMORIAL HOSPITAL  208-365-3561 x3342  EMMETT  ID
APAC CENTERS FOR PAIN MANAGEMENT  708-483-7007  WESTCHESTER  IL
APAC CENTERS FOR PAIN MANAGEMENT-  773-935-2760  CHICAGO  IL
THOREK MEMORIAL HOSPITAL  773 975-6734  CHICAGO  IL
AMBULATORY CARE CENTER LLC  812 475 1800  EVANSVILLE  IN
FORT WAYNE PHYSICAL MEDICINE  260-436-9337  FORT WAYNE  IN
OSMC OUTPATIENT SURGERY CENTER  574-266-4173  ELKHART  IN
SOUTH BEND CLINIC  574-237-9372  SOUTH BEND  IN
UNION HOSPITAL–  812 238 4964  TERRE HAUTE  IN
WELLSPRING  812-376-0700  COLUMBUS  IN
BALTIMORE PAIN MANAGEMENT  410 682-5040  BALTIMORE  MD
BERLIN INTERVENTIONAL PAIN MANAGEMENT  410 641 3759  BERLIN  MD
BOX HILL SURGERY CENTER  410 877 8141  ABINGDON  MD
GREENSPRING SURGERY CENTER  410 653 0077  BALTIMORE  MD
HARFORD COUNTY ASC, LLC  410 538 7000  EDGEWOOD  MD
PAIN MEDICINE SPECIALISTS  410 825 6945  TOWSON  MD
SURGCENTER OF BEL AIR  410 638 5523  BEL AIR  MD
MICHIGAN NEUROSURGICAL INST.  810 606 7112  GRAND BLANC  MI
MICHIGAN PAIN SPECIALISTS  734 995 7246  BRIGHTON  MI
NEUROMUSCULAR & REHABILITATION  231 935 0860  TRAVERSE CITY  MI
SOUTHEAST MICHIGAN SURGICAL HOSPITAL  586-427-1000  WARREN  MI
MAPS-EDINA MEDICAL PAIN CLINIC  763 537 6000  MINNEAPOLIS  MN
MAPS-MEDICAL ADVANCED PAIN  763 537 6000  FRIDLEY  MN
MEDICAL ADVANCED PAIN SPECIALISTS*  763-537-6000 x238  SHAKOPEE  MN
MEDICAL ADVANCED PAIN SPECIALISTS.  763 537 6000  MAPLE GROVE  MN
MINNESOTA SURGERY CENTER  763-767-7139  EDINA  MN
MINNESOTA SURGERY CENTER-  763 537 6000  MAPLE GROVE  MN
HIGH POINT SURGERY  336 878 6048  HIGH POINT  NC
NORTH CAROLINA ORTHOPAEDIC CLINIC  919 403 5148  DURHAM  NC
SURGERY CENTER OF WILSON  252-237-5649  WILSON  NC
DR. O'CONNELL'S PAIN CARE CTR  603-335-5070  MERRIMACK  NH
DR. O'CONNELL'S PAINCARE CENTERS, INC  603 692 3166  SOMERSWORTH  NH
CENTRAL JERSEY ORTHOPEDICS SPECIALISTS PC  908 561 2122  SOUTH PLAINFIELD  NJ
EDISON SURGICAL CENTER  732 452 0123  EDISON  NJ
IF PAIN ASSOCIATES / ISAIAH FLORENCE  201 287 1100  TEANECK  NJ
PREMIER ORTHOPEDICS SURG. ASSOC., LLC  856 690 1750  VINELAND  NJ
Comprehensive Pain Management  973 796 5216  SPARTA  NJ
SOUTH JERSEY HEALTH CARE  856 363 1558  ELMER  NJ
SOUTH JERSEY HEALTHCARE  856-641-7557  VINELAND  NJ
SAHARA SURGERY CENTER  702-362-7874  LAS VEGAS  NV
BUTANI, SUNIL H. PHYSICIAN PC  516 747 5042  MINEOLA  NY
OBOSA MEDICAL SERVICES  914-530-2323  MOUNT VERNON  NY
ROCHESTER BRAIN AND SPINE  585 334 5560  ROCHESTER  NY
BKC PAIN SPECIALISTS,LLC  740-387-7246  MARION  OH
CINCINNATI PAIN MANAGEMENT  513 891 0022  CINCINNATI  OH
MARION PAIN CLINIC  740-375-0200  MARION  OH
ORTHO-SPINE REHAB. CENTER, INC.     DUBLIN  OH
ALLEGHENY PAIN MANAGEMENT  814-940-2000  ALTOONA  PA
SOUTH HILLS PAIN & REHAB ASSOC.  412 469 7722  JEFFERSON HILLS  PA
NEW ENGLAND ANESTHESIOLOGY (NEA)  401-490-7530  WARWICK  RI
OCEAN STATE PAIN MANAGEMENT  401 766 7700  WOONSOCKET  RI
OCEAN STATE PAIN MANAGEMENT-  401 884 6070  EAST GREENWICH  RI
INTERVENE MD  843-216-4844  MOUNT PLEASANT  SC
PCA PAIN CARE CENTER-  865 835 5196  OAK RIDGE  TN
SPECIALTY SURGERY CENTER  931-484-2500 x125  CROSSVILLE  TN
ST. THOMAS OUTPATIENT NEUROSURGIACL  615 341 3425  NASHVILLE  TN
DALLAS BACK PAIN MANAGEMENT  214 445 5077  DALLAS  TX
HARRIS METHODIST SOUTHLAKE CENTER  817 748 8778  SOUTHLAKE  TX
INSIGHT IMAGING-ROANOKE  540 581 0882  ROANOKE  VA
NEW RIVER VALLEY SURGERY CENTER  540 639 5888  CHRISTIANSBURG  VA
PARS INTERVENTIONAL PAIN  304 865 7277  PARKERSBURG  WV

Steroid Recall, Ohio: Ohio facilities that received NECC medications

Ohio facilities that received NECC medications from May 21, 2012 to October 3, 2012, include:

Akron:

Akron Children’s Hospital

Ashland:

Ashland/Mansfield Foot & Ankle Specialists

Beachwood:

Contemporary Cosmetic Surgery

Surgcenter Cleveland LLC

Belpre:

Physicians Outpatient Surgery Center

Blue Ash:

Professional Radiology

Canfield:

Vitreo-Retinal Consultants

Canton:

Eye Centers of Ohio

Ohio Retina Associates

Vitreo Retinal Consultants

Chardon:

Smith Vein Institute

Cincinnati:

The Christ Hospital Spine Surgery Center

Cincinnati Eye Institute

Cincinnati Pain Management, Cornell Road

Greater Cincinnati Pain Management, Hunt Road

Medical Weight Management Center

Middletown Surgery Center, Franklin

Physicians Healthsource Inc.

Western Hills Interventional Pain

SW Ohio ASC, Middletown

Columbus:

Dublin Pain Clinic

Eye Center of Columbus

Mid-West Allergy Associates Inc.

New You Center for Advanced Medical Aesthetics

Taylor Station

Dayton:

Dayton Vitreo-Retinal Associates

Eye Laser and Surgery Center

Kunesh Eye Center

Samaritan North Surgery Center

Dublin:

Artemis Laser Vein Center

Dublin Physical Medicine

Ortho-Spine Rehab Center Inc.

Timeless Skin Solutions

Fairview Park:

Northcoast Opthalmology

Findlay:

Findlay Surgery Center

Franklin:

Middletown Surgery Center

Gahanna:

Scott Gurwin MD

Gallipolis:

Holzer Clinic

Kent:

Western Reserve Surgery Center

Lima:

Eye Surgery Center of Western Ohio

Lorain:

Roman A. Ringel MD

Mansfield:

Mansfield Foot and Ankle Specialists

Revision Advanced Surgery Center

Marion:

BKC Pain Specialists

Marion Pain Clinic

Marysville:

Marysville Surgical Center

Mayfield Heights:

Jason Leedy MD

Medina:

HMT Dermatology

Middleburg Heights:

Medical Eye Associates Inc.

Mentor:

Mentor Surgery Center

Vitreo Retinal Consultants - Mentor

Middletown:

SW Ohio ASC

Painesville:

Surgical Care Center (2165 Mentor Avenue)

Parma Heights:

Northern Ohio Eye Center

Portsmouth:

Eye Specialists of Ohio

Southern Ohio Medical Center

St. Clairsville:

Khoury Eye Center Inc.

Stow:

St. Clare Surgery Center

Tallmadge:

Novus Clinic

Toledo:

Advanced Pain Management

Toledo Clinic Outpatient Surgery Center

Westlake:

George Parras MD

Wilmington:

Eye Services LLC

Wooster:

Skin Care Solutions

Zanesville:

Insight Surgery & Laser Center LLC

http://cleveland.legalexaminer.com/fda-and-prescription-drugs/necc-news-ohio-clinics-from-akron-to-zanesville-that-received-necc-drugs-may-october-2012.aspx?googleid=305022&utm_source=feedburner&utm_medium=feed&utm_campaign=Feed%3A+injuryboard+%28InjuryBoard+Local+Blogs%29#