Consumer Lawyers

Archive for October, 2012|Monthly archive page

Ameridose Med Recall 10/31/12

In Uncategorized on October 31, 2012 at 10:02 pm

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 disclaimer icon. A complete list of all products subject to this recall can be accessed at www.ameridose.com disclaimer icon

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.
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Tainted Steroid Medications Recall- Meningitis news and notes for October 19, 2012

In FDA REcalls on October 19, 2012 at 6:41 pm

Contaminated steroids from New England Compounding Pharmacy have now killed 20 people in a fungal meningitis outbreak that began earlier this month, the CDC announced in it’s weekly outbreak update.

The CDC and FDA have also confirmed the presence of the fungus Exserohilum rostratum in one of the three lots of preservative-free methylprednisolone acetate — lot #08102012 — recalled on September 28, 2012. Testing on the other two lots is ongoing.

Exserohilum rostratum  has been isolated in 45 of the 47 patients with lab-confirmed fungal meningitis. As of October 18, 257 cases, including 3 peripheral joint infections, have been reported in 16 states.

Tennessee continues to have the highest burden of disease, reporting 63 cases and eight deaths. Other states where deaths have occurred include Michigan with four, Florida with three, and Indiana and Virginia with two deaths each.

CDC and state health departments estimate that approximately 14,000 patients may have received injections with medication from the three implicated steroid lots, and nearly 97% of these patients have been contacted for further follow-up.The CDC has also made a patient notification letter template  available for health-care providers who still need to notify patients that have been exposed to NECC medication.

http://www.clinicaladvisor.com/fungal-meningitis-death-toll-hits-20/article/264389/

 

From the CDC:

 

ackground
The Centers for Disease Control and Prevention (CDC) with state and local health departments and the Food and Drug Administration (FDA)External Web Site Icon are investigating a multistate meningitis outbreak of fungal infections among patients who have received a steroid injection of a potentially contaminated product into the spinal area. This form of meningitis is not contagious. The investigation also includes fungal infections associated with injections in a peripheral joint space, such as a knee, shoulder or ankle.

See Current Situation Update

How many cases have been reported?
Updates about the investigation, including case counts, are available at http://www.cdc.gov/hai/outbreaks/meningitis.html.

What is causing these infections?
The infections are caused by a fungus. At this point, the original source of the outbreak has not been determined; however, all infected patients identified thus far have received preservative-free (PF) methylprednisolone acetate (80mg/ml) from among the three lots voluntarily recalled by the New England Compounding Center in Framingham, Massachusetts, on September 26, 2012. These three lots are:

  • Methylprednisolone Acetate (PF) 80 mg/ml Injection, Lot #05212012@68, BUD 11/17/2012
  • Methylprednisolone Acetate (PF) 80 mg/ml Injection, Lot #06292012@26, BUD 12/26/2012
  • Methylprednisolone Acetate (PF) 80 mg/ml Injection, Lot #08102012@51, BUD 2/6/2013

These medications were used for other types of injections, including injections into the joint (e.g., knee). To date, CDC has only identified infections in patients who received epidural steroid injections with these medications. However, patients who received other types of injections with these products may also be at risk.

Which states received the potentially contaminated medication?
Twenty-three states have received medication from the New England Compounding Center.

The names of the facilities that have received medication from one of these lots are available athttp://www.cdc.gov/hai/outbreaks/meningitis-facilities-map.html.

Are other medications from the New England Compounding Center located in Framingham, Massachusetts associated with infections?
To date, CDC has not received reports of infections linked to other products from the New England Compounding Center. However, out of an abundance of caution, CDC recommends that patients cease use of any product produced by the New England Compounding Center until further information is available. A list of products produced by the New England Compounding Center can be found through the FDA website at http://www.fda.gov/Drugs/DrugSafety/ucm322734.htmExternal Web Site Icon.

If patients have taken or used medications from New England Compounding Center, and they are worried that they are ill because of use of one of these products, they should seek medical attention. Again, CDC has not received any reports of infection linked to other products from New England Compounding Center.

Are the treatment recommendations for infections that might be associated with other NECC products referenced by the FDA October 15 announcement the same as those for infections associated with methylprednisolone? 
This is preliminary information and CDC does not have firm evidence that fungal infections have been caused by exposure to other NECC products. Out of an abundance of caution, FDA has advised clinicians to follow up with patients to whom they have administered an injectable product, including an ophthalmic drug that is injectable or used in conjunction with eye surgery, or a cardioplegic solution purchased from or produced by NECC after May 21, 2012. Therefore, in patients who report signs and symptoms of infection following high-risk exposure to one of these NECC products (e.g., exposure of product to sterile body site), clinicians should perform a thorough diagnostic evaluation to exclude fungal infection. Consultation with an infectious diseases specialist is strongly encouraged to help make treatment decisions in these cases. If the evaluation of these patients is suggestive of fungal infection, please consult existing CDC treatment guidance http://www.cdc.gov/hai/outbreaks/clinicians/index.html

It is important to note that investigation of the mentioned patients is ongoing, and guidance may change if additional information becomes available.

Is there a role for prophylaxis or lumbar puncture in asymptomatic patients?

Prophylaxis
Currently, CDC emphasizes the need for rapid clinical evaluation and diagnosis, if indicated. Prophylaxis is not recommended at this time. For more information, please see Interim Guidance for Management of Asymptomatic Persons Exposed to Potentially Contaminated Steroid Products.

Lumbar Puncture
At this time, CDC does not recommend performing lumbar puncture in exposed patients who are currently asymptomatic. These patients should be closely monitored for development of symptoms, with a low threshold for performing lumbar puncture if the patient should become symptomatic. When diagnostic lumbar punctures are performed, they should be done through a site other than the site used for epidural injection when possible. The clinical investigation of patients associated with this outbreak is ongoing, and this recommendation may change as new information becomes available. For more information, please see Interim Guidance for Management of Asymptomatic Persons Exposed to Potentially Contaminated Steroid Products.

Can patients continue receiving treatment with epidural steroid injections?

It is not clear if or how additional epidural or intra-articular steroid injections may increase the risk of developing fungal meningitis or septic arthritis in patients who received epidural or intra-articular injections with a New England Compounding Center product and who are currently asymptomatic. Steroids are immunosuppressive and it is therefore possible they could increase risk in patients with sub-clinical infection; however, the duration of infection risk resulting from prior exposure to a contaminated steroid product is finite, albeit unknown. Patients should discuss the need for additional injections with their providers. For more information, please see Interim Guidance for Management of Asymptomatic Persons Exposed to Potentially Contaminated Steroid Products.

 

Meningitis Outbreak Map as of 10/19/2012

In Food Recalls on October 19, 2012 at 6:37 pm

Middle Georgia Facilities & Tainted Steroid Medications

In FDA REcalls on October 19, 2012 at 5:02 pm

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.
onths.

Federal criminal investigators raid tainted steroid maker NECC

In FDA REcalls on October 17, 2012 at 7:16 pm

Criminal investigators with the Department of Justice (DOJ) and the Food and Drug Administration (FDA) searched the New England Compounding Center (NECC), which is implicated in the multi-state outbreak of virulent fungal meningitis. Neither agency would comment on what they were looking for; however, two members of Congress have asked the DOJ to investigate whether the compounding center has violated any federal regulations. As the investigation heats up, the 14,000 individuals who received a steroid injection compounded by NECC are extremely concerned that they might contract a deadly fungal meningitis infection.

Source: http://www.emaxhealth.com/11306/federal-criminal-investigators-raid-tainted-steroid-maker-necc?utm_source=feedburner&utm_medium=feed&utm_campaign=Feed%3A+emaxhealth%2FhwBo+%28Emaxhealth+-+Daily+Heath+News+and+Articles%29

Meningitis Outbreak Map as of October 17, 2012

In Food Recalls on October 17, 2012 at 7:14 pm

Fungal meningitis outbreak investigation expanded to Arkansas

In FDA REcalls on October 17, 2012 at 5:45 pm

The Arkansas Department of Health (ADH) has announced that the multi state investigation into a fungal meningitis outbreak has been expanded.

According to ADH, all products manufactured by New England Compounding Center (NECC) in Massachusetts, a single compounding pharmacy, are now under this investigation. The expansion includes drugs shipped to Arkansas, but no fungal meningitis cases have been confirmed in the state so far.

A spokesperson with ADH said the department is in close contact with theFood and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) to identify all those products and the hospitals to which they have been sent, in order to assure that the products have been removed from shelves.

For now, these actions are only a precautionary measure, said Nate Smith, MD, Deputy Director and State Epidemiologist.

Region 8 News has checked with Arkansas Methodist Medical Center (AMMC); NEA Baptist Hospital, and St. Bernards Hospital to see if they have received any of the recalled products. AMMC, NEA, and St. Bernards say they have not received any products from the recalled Massachusetts plant.

So far, the Associated Press has reported 231 cases of fungal meningitis, two joint infections, and 15 deaths as a results of the outbreak.

States reporting affected patients are the following:  Florida, Idaho, Illinois, Indiana, Maryland, Michigan, Minnesota, New Hampshire, New Jersey, North Carolina, Ohio, Pennsylvania, Tennessee, Texas and Virginia.

http://www.kait8.com/story/19843504/fungal-meningitis-outbreak-investigation-expanded-to-arkansas

 

Granuflo News/Litigation for October 2012

In Product Recalls on October 16, 2012 at 8:34 pm

Fresenius is facing yet anotherGranuFlo wrongful death lawsuit, this one filed in the U.S. District Court for the Southern District of Georgia. The lawsuit was filed by Waddell Bishop, on behalf of his mother, Frances Carol Bishop. She died of a severe cardiovascular event in September 2010, after she was given GranuFlo during dialysis treatment.

The U.S. Food and Drug Administration (FDA) issued a Class 1 recall of GranuFlo and NaturaLyte earlier this year, after the products were linked to hundreds of deaths. Most of the deaths were caused by heart attacks, sudden cardiac arrest, cardiopulmonary arrest, or congestive heart failure during dialysis treatments.

In the complaint, which was filed on September 14, the plaintiff alleges that “neither the product label, packaging, instructions, nor the packages containing the product, provided adequate instructions and/or warnings regarding the use of GranuFlo and/or NaturaLyte.” Furthermore, the lawsuit alleges that if Fresenius had provided adequate instructions or warnings, the plaintiff and her doctors never would have used the product.

Fresenius is the global leader in dialysis treatment and products, and they manufactureGranuFlo and NaturaLyte. The products are intended to be added to a patient’s blood during dialysis treatment (when the blood is removed, cleaned, and returned to the patient’s body). Dialysis naturally disrupts the balance of acid in the bloodstream, so doctors have to add products to the blood to balance the acidity before returning it to the patient. GranuFlo and NaturaLyte both contain chemicals that the patient’s liver rapidly converts to bicarbonate. If a healthcare professional does not adjust the dosage to compensate for this, the patient can easily suffer a life-threatening bicarbonate overdose, cardiovascular event, and death.

 

Steroid Recall Injections: FDA: Pharmacy’s other drugs may be causing illness

In Uncategorized on October 15, 2012 at 8:58 pm

Two more drugs from a specialty pharmacy linked to a meningitis outbreak are now being investigated, U.S. health officials said, as they urged doctors to contact patients who got any kind of injection from the company.

The New England Compounding Center of Framingham, Mass., has been under scrutiny since last month, when a rare fungal form of meningitis was linked to its steroid shots used mostly for back pain.

Monday’s step by the Food and Drug Administration followed two developments. One was a report of a meningitis illness in a patient who got another type of steroid made by the company.

The agency also learned of two heart transplant patients who got fungal infections after being given a third product from the company during surgery.

 

The current outbreak has sickened 214 people, including 15 who have died. For weeks, officials have been urging doctors to contact patients who got shots of the company’s steroid methylprednisolone acetate, advise them about the risks of fungal infection, and urge them to take any meningitis symptoms seriously.

The steroid was recalled last month, and the company later shut down operations and recalled all the medicines it makes.

The FDA on Monday expanded its advice to doctors to contact all patients who got any injection made by the company, including steroids and drugs used in eye surgery as well as heart operations. The agency said it took the step “out of an abundance of caution” as it investigates the new reports involving the heart surgery drug and the second steroid, called triamcinolone acetonide.

 

http://www.wpri.com/dpps/health/healthy_living/fda-says-pharmacys-other-drugs-may-be-causing-illness-nd12-jgr_4787523

Starbucks Recalls Bistro Boxes for Possible Salmonella

In Uncategorized on October 15, 2012 at 8:53 pm

Starbucks Protein Bistro Boxes is being recalling because of possible Salmonella contamination.

Flying Food Group is voluntarily recalling Starbucks brand Protein Bistro Box with Enjoy By dates 8/10/12 to 10/6/12, which includes Justin’s Nut Butter 0.5-ounce single-serve Honey Peanut Butter squeeze packs.

According to the FDA,

The recalled peanut butter squeeze packs contained in the Protein Bistro Boxes have the following Best By dates: 7/14/13, 7/26/13, 7/27/13, 7/28/13, 7/29/13, 8/9/23, 8/10/13, 8/13/13, 8/14/13, 8/15/13, 8/26/13, 8/27/13, 8/28/13, 8/29/13, or 8/30/13.

Peanuts associated with the Sunland, Inc. recall were used in the production of certain lots of Justin’s Honey Peanut Butter squeeze pack product and have the potential to be contaminated with Salmonella.

Salmonella is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.

Flying Food Group is issuing this voluntary recall linked to the supplier’s recall to minimize any risk to public health.

The recalled product was distributed solely to Starbucks retail stores in Connecticut, Massachusetts, New York, New Jersey, Pennsylvania, Delaware, Maryland, District of Columbia, Virginia, Georgia, Florida, Illinois, Wisconsin, Minnesota, Indiana, Texas, Arizona, Nevada, and California from 8/8/12 to 10/4/12. All impacted product has been confirmed as removed from stores.

The Protein Bistro Box product is in a clear plastic container, with a white code date sticker on the bottom of the container, stating “Enjoy by” followed by the date in the following format: M (Month) DD (Date), for example, 08 08 standing for August 8th. The recalled Justin’s single-serve Honey Peanut Butter pouches are included inside the Protein Bistro Boxes and are fully labeled with the Justin’s brand and sealed. The individual pouches are dated stamped at the bottom of the pouch.

 

http://meriden.patch.com/articles/starbucks-recalls-bistro-boxes-for-possible-salmonella-56fcdc3c