FDA Issues Recall For L-Citrulline Supplement Used To Treat Urea Cycle Disorders

This is the update from last week:

The FDA alerts health care professionals and patients that Medisca is voluntarily recalling certain lots of its L-citrulline product after testing indicated that it does not contain any L-citrulline

• Testing by Medisca indicated that L-citrulline, lot numbers 95482/A, 95482/B, 95482/C, 95482/D and 96453/A, 96453/B, 96453/C, 96453/D do not contain L-citrulline. Pharmacists should see updated FDA Statement below for more product details.
• Medisca is voluntarily recalling all L-citrulline product with the above lot numbers.
• Health care professionals should discontinue dispensing from these lots, contact patients, and return all unused product to Medisca Inc. 
• Patients and caregivers should stop using any product with these lot numbers. 
• FDA has received several adverse event reports associated with Medisca’s L-citrulline product. FDA is investigating reports that may include additional lot numbers, continues to investigate the full scope of this issue and will continue to provide additional information as it becomes available. 
• Earlier, this information: FDA is notifiying health care professionals, patients, and caregivers of adverse events reported in patients who were administered L-citrulline repackaged and distributed by Medisca Inc. L-citrulline is used to treat certain urea cycle disorders, rare genetic disorders primarily diagnosed in children. FDA has received adverse event reports associated with potentially subpotent L-citrulline. Subpotent L-citrulline in patients with certain urea cycle defects can lead to high ammonia levels, which is serious and potentially life-threatening.In addition to the identified lot number 96453, FDA is investigating reports that may include additional lot numbers.
  BACKGROUND: Medisca supplies pharmacies nationwide with L-citrulline. The product is sold to pharmacies and clinics in containers filled with powdered L-citrulline, and it may be compounded into tablets, capsules, or liquids by pharmacies, or remain a powder.
  RECOMMENDATION: FDA recommends health care professionals quarantine lots of L-citrulline from Medisca and not administer to patients until FDA provides additional information.
  
   

FDA warns against using Uncle Ben’s Infused Rice

From the FDA:

Fast Facts

• Government officials are investigating a cluster of illnesses associated with Uncle Ben’s Infused Rice Mexican Flavor sold in 5- and 25-pound bags.
• Out of an abundance of caution, the FDA is warning food service companies and consumers not to use any Uncle Ben’s Infused Rice products sold in 5- and 25-pound bags.
• These products are sold to food service companies that typically distribute to restaurants, schools, hospitals and other commercial establishments. However, the products may be available over the Internet and at warehouse-type retailers. 
• Food service companies and consumers who have purchased the products should not use the rice, and should return it to their point of purchase or dispose of it.     
• Uncle Ben’s Brand Ready to Heat, Boxed, Bag or Cup products sold at grocery stores and other retail outlets are not being recalled.

 

What is the Problem and What is Being Done about the Problem?

 

The FDA, the Centers for Disease Control and Prevention (CDC), and state and local officials have been investigating a cluster of illnesses associated with Uncle Ben’s Infused Rice Mexican Flavor sold in 5- and 25-pound bags. 

On Feb. 7, 2014, the FDA’s Coordinated Outbreak Response and Evaluation Network (CORE) was notified of a cluster of illnesses at three public schools in Katy, Texas. Thirty-four students and four teachers experienced burning, itching rashes, headaches and nausea for 30 to 90 minutes, before the symptoms went away. Uncle Ben’s Infused Rice Mexican Flavor with the lot number 351EKGRV01, made by Mars Foodservices of Greenville, Miss., was the common food item eaten by ill students.

 

On Dec. 4, 2013, the Illinois Department of Public Health notified CDC of 25 children with similar skin reactions following a school lunch that served an Uncle Ben’s Infused Rice product. North Dakota reported a similar incident that occurred on Oct. 30, 2013. Three children in a daycare and one college student experienced flushing reactions 45 minutes after consuming an Uncle Ben’s Infused Rice product.

 

Mars Foodservices is recalling all bags and all lot numbers of its Uncle Ben’s Infused Rice products produced in 2013: 

• UNCLE BEN’S INFUSED Rice Roasted Chicken Flavor (5- and 25-pounds)
• UNCLE BEN’S INFUSED Rice Garlic & Butter Flavor (5-pounds)
• UNCLE BEN’S INFUSED Rice Mexican Flavor (5- and 25-pounds)
• UNCLE BEN’S INFUSED Rice Pilaf (5-pounds)
• UNCLE BEN’S INFUSED Rice Saffron Flavor (5-pounds)
• UNCLE BEN’S INFUSED Rice Cheese Flavor (5-pounds)
• UNCLE BEN'S INFUSED Rice Spanish Flavor (25-pounds)

 

Although this product is not typically marketed to individual consumers, it may be available over the Internet and at warehouse-type retailers.

 

Uncle Ben’s Brand Ready to Heat, Boxed, Bag or Cup products sold at grocery stores and other retail outlets are not being recalled.

 

Investigation into this outbreak continues. 

 

What are the Symptoms of Illness/Injury?
The symptoms associated with this illness include a red burning/itching rash, headache, nausea, and flushness of the skin.

 

The symptoms appear very shortly after consuming the rice product and pass within 30 to 90 minutes.

 

 

What Specific Products are being Recalled? 

Mars Foodservices is recalling all bags and all lot numbers of its Uncle Ben’s Infused Rice products produced in 2013:

• UNCLE BEN’S INFUSED Rice Roasted Chicken Flavor (5- and 25-pounds)
• UNCLE BEN’S INFUSED Rice Garlic & Butter Flavor (5-pounds)
• UNCLE BEN’S INFUSED Rice Mexican Flavor (5- and 25-pounds)
• UNCLE BEN’S INFUSED Rice Pilaf (5-pounds)
• UNCLE BEN’S INFUSED Rice Saffron Flavor (5-pounds)
• UNCLE BEN’S INFUSED Rice Cheese Flavor (5-pounds)
• UNCLE BEN'S INFUSED Rice Spanish Flavor (25-pounds)

Low Testosterone Medications and Gels – Increased Risk of Non-fatal Myocardial Infarction?

Attorneys in my office are investigating a claimed link between these medications and heart injuries:
404 373 1800

Testosterone: What is it. In the fetal and embryonic stages of development, testosterone promotes the development of the scrotum and the formation of the structures involved in production. 

In adulthood, testosterone may play a part in sexual function, libido, hair loss, and it may play a role in the accumulation of abdominal fat.As men age, their testorone levels may slowly decline. This occurrence has been called “viripause”, “andropause” or “male menopause.”

This menopause may be caused by the testosterone receptors becoming less receptive, while the amount of free testorone in the body decreases. The decrease is due to an increase in a blood protein that binds with the hormone, rendering it useless.

The gradual fall in the testosterone levels (from 30 to 40 percent) is common in men between the ages of 48 and 70. As testosterone levels drop, men may experience a loss in muscle strength and function, increase in body fat, decrease in body density and a decrease in sexual function and drive. Of course, your physician first needs to rule out other medical causes for those changes.

From a study release in January, 2014, there is this discussion point: In older men, and in younger men with pre-existing diagnosed heart disease, the risk of MI following initiation of TT prescription is substantially increased.

From the study:

We examined risk of MI with TT prescription in all subjects. Since previous studies indicated that cardiovascular events appeared early in treatment, we focused on the 90 day interval following the filling of a first prescription. For those who did not refill their prescription, we also assessed the interval of 91–180 days. To examine potential effect modification by pre-existing disease, we estimated the effect of TT prescription by prior history of a heart disease diagnosis (ICD-9: 404, 414–414.07, 420–429). We also examined the RR for PDE5I and compared the RRs in the TT prescription and PDE5I cohorts.

Also:

Among men aged 65 years and older, we observed a two-fold increase in the risk of MI in the 90 days after filling an initial TT prescription, the risk declined to baseline in the 91 to 180 days after initial TT prescription, among those who did not refill their prescription. Since we censored follow-up at the first refill, and the supply for most prescriptions was 30 to 90 days, it is likely that there was little use of the medication in the 91 to 180 day post-prescription interval when the risk declined.

What are the products?

Testosterone therapy is most often administered as a gel, patch or injection. The following products treat low testosterone:

• Androderm (Actavis) – patch applied to the skin
• AndroGel (AbbVie Inc.) – topical gel applied to the skin
• Axiron (Lilly USA, LLC) – topical cream applied to underarm
• Bio-T-Gel (Teva Pharmaceuticals) – topical gel applied to skin
• Delatestryl (Endo Pharmaceuticals) – injection or solution
• Depo-Testosterone (Unigen Life Sciences) – injection solution
• Fortesta (Endo Pharmaceuticals) – topical gel applied to skin
• Striant (Auxilium Pharmaceuticals) – buccal tablet absorbed through the gums
• Testim (Auxilium Pharmaceuticals) – topical gel applied to skin
• Testopel (Auxilium Pharmaceuticals) – subcutaneous pellet

Risks of testosterone therapy

Men undergoing low T therapy with the following signs of health problems had the greatest increased risk of suffering a heart attack or stroke while taking low T treatments.

• plaque buildup
• artery blockage
• high cholesterol
• diabetes
• obesity

One doctor has explained: Testosterone increases the production of red blood cells, which can clump together or coagulate, essentially making blood thicker. That may be especially hazardous in men who have narrowed arteries because of aging and disease.

Talk with us if you think that you have a serious heart condition that you worry may be linked to use of any one of these products

- See more at: http://triallawyercenter.com/2014/02/12/low-testosterone-medications-and-gels-increased-risk-of-non-fatal-myocardial-infarction/#sthash.6vmbt6np.dpuf

CHANGING THE RULES OF THE GAME: THE PROPOSED AMENDMENTS TO FEDERAL CIVIL RULES SEEK TO ADD NEW LIMITS ON DISCOVERY-

My good friend, Attorney Mark Chalos recently wrote about the proposed changes to the Federal Rules of Civil Procedure. His blog post is a must read.  Take three minutes and let your legislators know that you opposed these rule changes:


 From his post:

Opponents argue that the data establish that the present 10 deposition limit and the current number of other allowable discovery requests are working well in practice and changes are unnecessary.  Some opponents suggest that further discovery restrictions discovery would be unfair to claimants who have the ultimate burden of proof in the litigation. Moreover, interrogatories and requests for admissions provide low cost means for discovering information and narrowing issues for trials and, therefore, new limitations of these mechanisms would provide little or no cost-savings.

 See more at: http://blog.legalsolutions.thomsonreuters.com/practice-management-2/changing-rules-game-proposed-amendments-federal-civil-rules-seek-add-new-limits-discovery/#sthash.9aKLHfDh.dpuf

The Post Mensing fight continue

AAJ continue to advocate on how best to limit the effects of Mensing on plaintiffs who have already been injured by generic drugs.

A different case: Brinkley v. Pliva, Inc.

One such case is Brinkley v. Pliva, Inc., currently pending in the U.S. Court of Appeals for the Eighth Circuit. The Brinkley case is similar to Mensing in that the injured patients took the drug metoclopramide (the generic form of the drug Reglan) and developed tardive dyskinesia, a severe and often irreversible neurological disorder.

Brinkley's lawyers, Benjamin A. Bertram and J. Scott Bertram of Betram & Graf in Kansas City, Missouri; David M. Peterson and Nicholas S. Clevenger of Peterson & Associates in Kansas City, Missouri; Thomas J. Preuss of Wagstaff & Cartmell in Kansas City, Missouri; Daniel J. McGlynn and Terrence J. Donahue, Jr., of McGlynn, Glisson, Moulton in Baton Rouge, Louisiana; and Bill Curtis hired CCL to work on the appeal. CCL's Senior Litigation Counsel Louis Bograd, who argued on behalf of Gladys Mensing before the Supreme Court, is handling the appeal for Ms. Brinkley.

Brinkley differs from Mensing in that the plaintiff used generic metoclopramide after July 2004, when the FDA approved a new warning against long-term use for the Reglan label. Pliva, the manufacturer of the generic metoclopramide Ms. Brinkley took, never added this new warning to its labeling, but it could have. Once the change to the Reglan label had been approved, federal regulations permitted Pliva to add the same warning to its label without prior agency action.

Bograd says that, because federal law would have permitted this label change, Pliva may be held accountable and a state-law claim for failure to warn is not preempted by federal law.

The Sixth Circuit and many lower courts agree that claims like Brinkley's are not preempted, but the Fifth Circuit has rejected this argument. Brinkley provides an opportunity for the Eighth Circuit to weigh in on this issue.

The bottom line is that all drug manufacturers should have a duty to warn patients of the risks of using their products. Accountability matters, and this case may prove pivotal in advancing this cause for patients injured or killed by dangerous generic drugs before the FDA's new proposed rule can take effect.  

Rohto Eye Drops - Mentholatum: Recall - Sterility Control Review

The Mentholatum Company announced a voluntary recall of Rohto Arctic, Rohto Ice, Rohto Hydra, Rohto Relief and Rohto Cool eye drops. The recall was initiated due to a manufacturing review at the production facility in Vietnam involving sterility controls. To date, there has been no evidence indicating that product does not meet specifications.

BACKGROUND: The products are sold nationwide over-the-counter at pharmacies and retail stores. This recall includes only lots of product that were manufactured in Vietnam. This recall affects Rohto Arctic, Rohto Ice, Rohto Hydra, Rohto Relief and Rohto Cool eye drops that were made in Vietnam only, which can be identified by the words "Made in Vietnam" on the side carton panel under the company name and address information, as well as on the back label of the bottle. The lot numbers for products made in Vietnam will include the letter "V," for example, "Lot 3E1V," and will be located on the bottom panel of the carton, and on the bottom of the eye drop bottle.

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm382097.htm

Trufill n-BCA Liquid Embolic System by Codman Neuro: Recall - Incorrect Instructions For Use

Codman Neuro is informing physicians of this incorrect statement and updating the product's Instructions For Use (IFU). The product's IFU incorrectly noted: "A 2:1 (67% Ethiodized Oil / 33% nBCA) for feeding pedicle injections close to the nidus at high flow rates where venous opacification occurs on contrast injections within 1/2 second." The use of incorrectly mixed product can result in the liquid mixture solidifying too slowly in unintended areas, which may lead to embolization or reflux into arteries and pulmonary vessels. This could result in significant impact to the patient, including neurological deficits, pulmonary emboli and possibly death.

The correct information should have stated: "A 2:1 (67% Ethiodized Oil / 33% nBCA) for Intranidal injections without AV fistulae or high flow rates in order to more deeply penetrate the nidus."

BACKGROUND: Trufill n-BCA is indicated for embolization of cerebral arteriovenous malformations (AVMs) when presurgical devascularization is desired. In October 2013, Codman Neuro identified an incorrect statement in the product's IFU that described suggested mixing ratios for use in certain treatment conditions.

Product is not being removed from the market. Trufill nBCA products associated with the correction notice were manufactured between February 25, 2010 and October, 31, 2013, distributed to hospitals and surgical centers, and include the following product codes (all lots): 631400 (Two 1 gram tubes nBCA) and 631500 (One 1 gram tube nBCA).

RECOMMENDATION: All customers who have purchased Trufill nBCA are reminded to review the correction notice and other product literature to ensure proper mixing procedures are followed. They may also call Codman Neuro with questions or to report any malfunction or adverse event on weekdays between the hours of 7:00am and 6:30pm Eastern Time at 1-866-491-0974, Option 2.

Health care providers and consumers may report adverse events or quality problems experienced with the use of any Main Street products to the FDA’s MedWatch Adverse Event Reporting program:

Fresenius Recall 2014

On Jan. 16, 2014, Fresenius issued a Class 2 recall for its 2008 Series of hemodialysis machines after saline bags were inappropriately filling during setup and recirculation. This recall affected 111,504 machines in North America and included the following models: 2008H, 2008K, 2008K2, 2008k@Home and 2008T.

http://www.nephrologynews.com/articles/109985-fda-recalls-fresenius-2008-series-dialysis-machines

FDA warns of possible harm from exceeding recommended dose of over-the-counter sodium phosphate products to treat constipation

The U.S. Food and Drug Administration (FDA) is warning that using more than one dose in 24 hours of over-the-counter (OTC) sodium phosphate drugs to treat constipation can cause rare but serious harm to the kidneys and heart, and even death.  OTC sodium phosphate drug products include oral solutions taken by mouth and enemas used rectally.  Consumers and health care professionals should always read the Drug Facts label for OTC sodium phosphate drugs and use these products as recommended on the label, and not exceed the labeled dose.  Caregivers should not give the oral products to children 5 years and younger without first discussing with a health care professional. 

Health care professionals should use caution when recommending an oral dose of these products for children 5 years and younger.  The rectal form of these products should never be given to children younger than 2 years.

FDA has become aware of reports of severe dehydration and changes in the levels of serum electrolytes from taking more than the recommended dose of OTC sodium phosphate products, resulting in serious adverse effects on organs, such as the kidneys and heart, and in some cases resulting in death. These serum electrolytes include calcium, sodium, and phosphate. According to the reports, most cases of serious harm occurred with a single dose of sodium phosphate that was larger than recommended or with more than one dose in a day.   
Some individuals may be at higher risk for potential adverse events when the recommended dose of
OTC sodium phosphate is exceeded.

These individuals include young children; individuals older than 55 years; patients who are dehydrated; patients with kidney disease, bowel obstruction, or inflammation of the bowel; and patients who are using medications that may affect kidney function. These medications include diuretics or water pills; angiotensin converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) used to treat high blood pressure; and nonsteroidal anti-inflammatory drugs (NSAIDs) such as aspirin, ibuprofen, and naproxen.

http://www.fda.gov/Drugs/DrugSafety/ucm380757.htm

FDA: Acetaminophen doses over 325 mg might lead to liver damage

The Food and Drug Administration is asking doctors to stop prescribing combination medications that contain more than 325 milligrams of acetaminophen per pill, because of long-standing concerns about liver damage.

FDA is recommending health care professionals discontinue prescribing and dispensing prescription combination drug products that contain more than 325 milligrams (mg) of acetaminophen per tablet, capsule, or other dosage unit. There are no available data to show that taking more than 325 mg of acetaminophen per dosage unit provides additional benefit that outweighs the added risks for liver injury. Further, limiting the amount of acetaminophen per dosage unit will reduce the risk of severe liver injury from inadvertent acetaminophen overdose, which can lead to liver failure, liver transplant, and death.

We recommend that health care providers consider prescribing combination drug products that contain 325 mg or less of acetaminophen. We also recommend that when a pharmacist receives a prescription for a combination product with more than 325 mg of acetaminophen per dosage unit that they contact the prescriber to discuss a product with a lower dose of acetaminophen. A two tablet or two capsule dose may still be prescribed, if appropriate. In that case, the total dose of acetaminophen would be 650 mg (the amount in two 325 mg dosage units). When making individual dosing determinations, health care providers should always consider the amounts of both the acetaminophen and the opioid components in the prescription combination drug product.

In January 2011 we asked manufacturers of prescription combination drug products containing acetaminophen to limit the amount of acetaminophen to no more than 325 mg in each tablet or capsule by January 14, 2014. We requested this action to protect consumers from the risk of severe liver damage which can result from taking too much acetaminophen. This category of prescription drugs combines acetaminophen with another ingredient intended to treat pain (most often an opioid), and these products are commonly prescribed to consumers for pain, such as pain from acute injuries, post-operative pain, or pain following dental procedures.

More than half of manufacturers have voluntarily complied with our request. However, some prescription combination drug products containing more than 325 mg of acetaminophen per dosage unit remain available.

In the near future we intend to institute proceedings to withdraw approval of prescription combination drug products containing more than 325 mg of acetaminophen per dosage unit that remain on the market.
Cases of severe liver injury with acetaminophen have occurred in patients who:

• took more than the prescribed dose of an acetaminophen-containing product in a 24-hour period;
• took more than one acetaminophen-containing product at the same time; or
• drank alcohol while taking acetaminophen products.

http://www.fda.gov/Drugs/DrugSafety/ucm381644

Are energy drinks safe?

In the podcast “A Cup of Health with CDC” by the Centers for Disease Control and Prevention (CDC), Dr. Robin Toblin, researcher at the Walter Reed Army Institute of Research said, “Right now the safety of these products isn’t really known. They’re not generally regulated by the FDA.” 

According to a study in the CDC’s Morbidity and Mortality Weekly Report, researchers found that U.S. Service Members on combat deployment in Afghanistan reported having sleep problems.

Read more here: http://www.starherald.com/news/local_news/are-energy-drinks-safe/article_e524b771-6afc-56f2-aee4-bb767913bbed.html

Update on Emergency Department Visits Involving Energy Drinks: A Continuing Public Health Concern

From the DAWN Report/Network:

Energy drinks are flavored beverages containing high amounts of caffeine and typically other additives, such as vitamins, taurine, herbal supplements, creatine, sugars, and guarana, a plant product containing concentrated caffeine. These drinks are sold in cans and bottles and are readily available in grocery stores, vending machines, convenience stores, and bars and other venues where alcohol is sold. These beverages provide high doses of caffeine that stimulate the central nervous system and cardiovascular system. The total amount of caffeine in a can or bottle of an energy drink varies from about 80 to more than 500 milligrams (mg), compared with about 100 mg in a 5-ounce cup of coffee or 50 mg in a 12-ounce cola.¹ Research suggests that certain additives may compound the stimulant effects of caffeine. Some types of energy drinks may also contain alcohol, producing a hazardous combination; however, this report focuses only on the dangerous effects of energy drinks that do not have alcohol.

Although consumed by a range of age groups, energy drinks were originally marketed to appeal to youths and were reported to have been consumed by 30 to 50 percent of children, adolescents, and young adults.² Marketing suggests benefits such as increased energy and stamina, weight loss, and enhanced physical and mental performance.² More concentrated forms of energy drinks, known as energy shots, have become increasingly popular among a wider range of age groups, including older adults.³ Marketing analysts reported increasing sales of energy shots in 2011 that were expected to continue through 2012.³ The concentrated amount of caffeine and other ingredients in these drinks has come under scrutiny as the Food and Drug Administration disclosed reports of adverse events with mention of the popular energy shot 5-Hour Energy.⁴

Consumption of energy drinks is a rising public health problem because medical and behavioral consequences can result from excessive caffeine intake. A growing body of scientific evidence documents harmful health effects of energy drinks, particularly for children, adolescents, and young adults.² Research has established that, among college students, there are associations between energy drink consumption and problematic behaviors such as marijuana use, sexual risk taking, fighting, smoking, drinking, and prescription drug misuse.^5,6 In one study, bar patrons who consumed alcohol mixed with energy drinks were 3 times more likely to leave a bar highly intoxicated and were 4 times more likely to intend to drive while intoxicated than those who did not consume alcohol mixed with energy drinks.⁶ This latter finding may be because the high levels of caffeine found in energy drinks can mask the symptoms associated with being intoxicated (e.g., feeling lethargic). Individuals, especially young drinkers, may incorrectly believe that consumption of caffeine can "undo" the effects of alcohol intake and make it safe to drive after drinking. Because of the popularity of energy drinks and the burgeoning literature suggesting the risks involved with their use, gaining additional information about these beverages is important.

The Drug Abuse Warning Network (DAWN) is a public health surveillance system that monitors drug-related emergency department (ED) visits in the United States and can be used as a source of information for assessing the more negative medical consequences associated with consuming energy drinks. To be a DAWN case, the ED visit must involve a drug, either as the direct cause of the visit or as a contributing factor. Such a visit is referred to as a "drug-related visit." Drugs include alcohol; illegal drugs, such as cocaine, heroin, and marijuana; pharmaceuticals (e.g., over-the-counter medicines and prescription medications); and nutraceuticals, such as nutritional supplements, vitamins, and caffeine products. A previous report addressing ED visits involving energy drinks was published using 2009 data⁷; this issue of The DAWN Report highlights trend data for energy drinks from 2007 to 2011, as well as drug combinations found in 2011.

http://www.samhsa.gov/data/2k13/DAWN126/sr126-energy-drinks-use.htm

Thyroid Supplements With a Kick

From the NYT blog and a study. 

"Thyroxine and Triiodothyronine Content in Commercially Available Thyroid Health Supplements"

From that article: Dietary and herbal thyroid supplements marketed to improve thyroid health or support thyroid function so as to improve energy and/or promote weight reduction appeal to many patients who are under the misconception that herbalproducts are safer than conventional medications. 

Herbscommonly found in the active ingredients were iodine-richsubstances such as kelp or bladderwrack (F. vesiculosus), or substances believed to be thyroid stimulants, Ashwagandha

root (W. somnifera),C. forskohlii, or guggul based on animalstudies. Kelp or bladderwrack are used as a source of iodine in herbal medicine to treat patients with underactive thyroidglands. Large doses of iodine may occasionally precipitate a reversible hyperthyroidism in patients with underlying autoimmune thyroid autonomy.

 

 http://online.liebertpub.com/doi/pdf/10.1089/thy.2013.0101

Ranbaxy Drugs at Fourth Plant Banned From U.S. Market

Ranbaxy Laboratories Ltd. can’t make or distribute drug ingredients from a fourth plant in India for the U.S. market, regulators ordered.

A U.S. Food and Drug Administration inspection of Ranbaxy’s Toansa facility found that workers retested drug products to produce acceptable findings after the items originally failed analytical testing.

 http://www.bloomberg.com/news/2014-01-23/ranbaxy-drugs-at-fourth-plant-banned-from-u-s-market.html

Midwest Wholesale Issues Voluntary Recall of Boost Ultra and other Dietary Supplements

From the Dietary Supplement Reporter:

• About us: Lawyers in GA/FL 404 451 7781
• Durbin – FDA

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The Dietary Supplement Reporter

Lawyers investigating unsafe dietary supplements; call us at 404-451-7781

Nixa, MO, Midwest Wholesale is voluntarily recalling the following products and Lot numbers.

List of Products included in this Recall:
Boost Ultra
12 pill bottle, Lot#B70130, Exp 03/15
3 pill bottle, Lot#B70130, Exp 3/2015
1 pill pack, Lot#06012011, Exp 6/2014
XZone Gold
1 pill pack, Lot#130710GL, Exp 7/31/18
Sexy Monkey
1 pill pack, Exp 12/31/14
Triple MiracleZen Platinum
1 pill pack, Lot# OAWF1027, Exp 1/31/15 and Lot# OAWF1003, Exp 1/31/15
Magic for Men
12 pill bottle, Lot# GP808, Exp 10/16
1 pill pack, Lot#BN030613, Exp 2/6/15
“New” Extenze
30 pill box, Lot# 0512058, Exp 05/16
New XZen Platinum
1 pill pack, Lot#130520PL, Exp 5/31/17

This recall is being conducted to the consumer level. FDA analysis found these products to contain undeclared Sildenafil and/or Tadalafil, the active ingredients in FDA-approved prescription drugs used to treat erectile dysfunction (ED). These undeclared ingredients 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.
Consumers should stop using this product immediately and throw it away. Consumers who have experienced any negative side effects should consult a health care professional as soon as possible.

These products are labeled and intended to be used as dietary supplements for sexual enhancement. The products are packaged in 1 capsule blister packs, 3 pill bottles, 6 pill bottles, 12 pill bottles and 30 tablet boxes. These products were distributed to 20 selected retail locations in several states by Midwest Wholesale from August 1, 2013 to October 22, 2013.
Midwest Wholesale is notifying its retailers and customers by telephone and recall letter and is arranging for return of all recalled products. Consumers and retailers that have these products which are being recalled should stop consumption or further distribution and return to place of purchase or directly to Midwest Wholesale, 617 N Althea Ave, Nixa, MO 65714.
Consumers are requested to have their order number or proof of purchase.
Consumers with questions regarding this recall can contact Midwest Wholesale by phone (888-514-7110), Monday to Friday, 09:00am-5:00pm, Central Time. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch-Adverse Event Reporting program either online, by regular mail or by fax.

 http://dietarysupplementreporter.wordpress.com/2014/01/15/midwest-wholesale-issues-voluntary-recall-of-boost-ultra-and-other-dietary-supplements/

Nationwide Recall of Two Lots of Soliris® (eculizumab) Concentrated Solution for Intravenous Infusion

From the FDA, and update on this recall: 

Alexion Pharmaceuticals, Inc. (NASDAQ: ALXN)today is providing further information regarding a previously communicated voluntary recall of two lots of Soliris ® (eculizumab) Concentrated Solution for Intravenous Infusion. As stated on Nov. 12, 2013, the two lots were found to contain visible particles. At that time, Alexion provided instructions to return any unused vials of Soliris from these two lots at the distributor level. Alexion is now providing the same instructions at the hospital/user level.

The administration of particulate, if present in a parenteral drug, poses a potential safety risk to patients in two general areas: immunogenicity and thromboembolic events. Particulates could cause blockage of flow of blood in vessels, which could be life-threatening. To date, there have been no product complaints of particulates, or identifiable safety concerns attributed to the product consumed from the affected lots. As previously stated, Alexion does not anticipate any interruption to patient supply of Soliris.

The product is approved as a treatment for patients with paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome, two ultra-rare disorders. Alexion and its distributors typically ship Soliris to healthcare providers in small quantities, which are timed to individual patient infusions, with the product being consumed before more is shipped. As product was last shipped on Nov. 1, 2013, Alexion believes there is little, if any, inventory currently being held at the hospital or user level.

The following table lists the two affected lots, which were distributed nationwide.

Product	Lot	Expiration Date	First Ship Date	Last Ship Date
Soliris® (eculizumab) 300 mg/30 mL Concentrated solution for intravenous infusion only NDC 25682-001-01	10010A	Oct. 31, 2015	Oct. 11, 2013	Nov. 1, 2013
	10001-1	July 31, 2014	June 4, 2012	May 8, 2013

As previously disclosed, Alexion believes that it has identified the filling process step that resulted in the presence of the visible particles and implemented the change necessary to correct the issue. To date, visible particles have not been observed in other lots of Soliris distributed in the U.S.

Tandem Diabetes Care Initiates Voluntary Recall for Specific Lots of Insulin Cartridges Used with t:slim Insulin Pump

andem Diabetes Care®, Inc. (NASDAQ: TNDM) today announced that it is initiating a voluntary recall of specific lots of insulin cartridges that are used with the t:slim® Insulin Pump. The affected cartridges may be at risk for leaking. The cause of the recall was identified during Tandem's internal product testing, and has not been associated with any complaints or adverse events reported by customers. However, a cartridge leak could potentially result in the device delivering too much or too little insulin, which can lead to a serious adverse event.



Customers should discontinue using cartridges labeled with the below lot numbers, which were shipped on or after December 17, 2013. The affected lots represent approximately 4,746 boxes of cartridges (10 cartridges per box).

Affected Lot Numbers
M001963	M001980	M002027	M002083	M002119
M001964	M001987	M002028	M002096	M002120
M001973	M001988	M002029	M002097
M001974	M001990	M002030	M002099
M001979	M001991	M002082	M002100

All other cartridge lots and the t:slim Insulin Pump are not affected by this recall. Customers who received affected cartridges are being contacted by the Company or its authorized distributors and asked to call Tandem Technical Support to receive replacement cartridges at no charge. Tandem expects to have sufficient quantities of cartridges to replace affected lots in a timely manner. Tandem Customer Support is available 24 hours a day, 7 days a week at 1-877-801-6901.
 http://www.fda.gov/Safety/Recalls/ucm381473.htm

Human Science Foundation Issues Nationwide Recall of Pro ArthMax Due to Undeclared Active Pharmaceutical Ingredients

Human Science Foundation is voluntarily recalling all lots of Pro ArthMax 120 count bottle, labeled and sold as a dietary supplement to the consumer level. The product has been found to contain undeclared active pharmaceutical ingredients (APIs), making it an unapproved new drug. FDA sample analysis tested the product to contain the following APIs: 2.4mg of Chlorzoxazone, 0.78mg of Nefopam, 2.5mg of Diclofenac, 7.7mg of Ibuprofen, 2.1mg of Naproxen, and 1.9mg of Indomethacin.

Use of this product containing the undeclared drug ingredients listed above, has a reasonable probability of resulting in fatal adverse events in consumers and patients with underlying illnesses, including known allergy to the hidden ingredients, cardiac, gastrointestinal, hepatic, and renal conditions as well as patients who recently undergone cardiac bypass graft surgery. Consumers would be unaware that the product contains Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) (and other ingredients), may inadvertently overdose by taking another NSAID concurrently, thus increasing the risk for NSAID associated adverse events, which include but are not limited to, myocardial infarction, stroke, congestive heart failure, renal toxicity, and bleeding, ulceration, or perforation of the stomach or intestines.

The product is marketed as a dietary supplement for joint pain and arthritis and is packaged in 120-count tablets per bottle, in a white plastic screw top bottle. Product was distributed to direct consignees in the state of California then further distributed nationwide to retail stores and via internet sales.

Company is notifying its distributors and customers by telephone and e-mail and is arranging for return for credit of all recalled products. Consumers/distributors/retailers that have product which is being recalled should stop using and return to place of purchase for credit.

Consumers with questions regarding this recall can contact Human Science Foundation by email to hsf@hs-foundation.com from Monday through Friday, 10 AM and 4 PM, PST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

 http://www.fda.gov/Safety/Recalls/ucm381494.htm

Hospira Issues a Voluntary Nationwide Recall of One Lot of Lidocaine HCl Injection, USP, 2%, 5 Ml in 5 Ml Vial

Hospira, Inc. announced it initiated a voluntary nationwide recall to the user level for one lot of Lidocaine HCl Injection, USP, 2%, 5 mL Single-Dose Vial (NDC 0409-2066-05), Lot 32-135-DD, expiration date 1AUG2015. The recall is due to a reddish orange particulate on the inner surface and floating in the solution.

If particulate goes undetected and solution is administered, the particle may potentially block the infusion of the solution to the patient, resulting in a delay in therapy. If smaller pieces of the particulate break off and become free floating within the solution, they may pass through the catheter into the patient, resulting in local inflammation or mechanical disruption of tissue. Chronically, following sequestration, local granuloma formulation is possible. In consideration of the reddish orange color of the particulate, if there is iron within the particle that is infused, it may put a patient at risk when undergoing MRI (strong magnetic field exposure), as the particle could potentially be dislodged and be pulled through tissue, causing local inflammation and tissue trauma.

Lidocaine is packaged 10 units per carton/180 units per case in single dose glass fliptop vials.

The recalled lot was distributed to distributors/wholesalers, hospitals, and pharmacies located in AL, AZ, CA, CO, FL, GA, HI, IL, IN, KY, LA, MD, MA, MI, MS, MO, NV, NJ, NC, OH, OK, PA, TN, TX, UT, VA, WA, and WI between September 2013 through October 2013. Hospira became aware of the issue after receiving a complaint of particles in the glass vial. To date, Hospira has not received reports of any adverse events associated with this issue for this lot. Hospira believes the embedded particulate is related to a supplier’s glass defect.

Anyone with an existing inventory should immediately stop use and quarantine any affected product and return the product to Stericycle. Hospira will be notifying its direct distributors/customers via a recall letter and will arrange for impacted product to be returned to Stericycle for returns processing. 

For additional assistance, call Stericycle at 1-855-695-8596 between 8 a.m. and 5 p.m., ET, Monday through Friday.

 http://www.fda.gov/Safety/Recalls/ucm379739.htm

For clinical inquiries, please contact Hospira using the information provided below.

Hospira Contact	Contact Information	Areas of Support
Hospira Global Complaint Management	1-800-441-4100 (8am-5pm CT, M-F) (ProductComplaintsPP@hospira.com)	To report adverse events or product complaints
Hospira Medical Communications	1-800-615-0187 or medcom@hospira.com (Available 24 hours a day/7 days per week)	Medical inquiries

DePuy LPS Diaphyseal Sleeve News

In a Sept. 24, 2013 update of the Class 1 Recall issued Feb. 15, 2013, the FDA said it "has received a total of 10 reports (6 fractures and 4 reports of loosening that may or may not be attributed to the same device design issue) of incidents in which the device has malfunctioned."

This is the report from 2013:

ISSUE: FDA notified healthcare professionals of a Class I recall of the LPS Diaphyseal Sleeve. The LPS Diaphyseal Sleeve to Diaphyseal Sleeve Base taper connection may not be sufficient to accommodate potential physiologic loads that may be transferred to the junction during normal gait activities by some patients. This may result in fracture of the sleeve at the taper joint which may also lead to loss of function or loss of limb, infection, compromised soft tissue or death.

The FDA has received a total of 10 reports (6 fractures and 4 reports of loosening that may or may not be attributed to the same device design issue) of incidents in which the device has malfunctioned.

The affected devices were manufactured from 2008 to July 20, 2012. See the Recall notice for a list of affected product codes and lot numbers.

BACKGROUND: The LPS Diaphyseal Sleeve is intended for use with the LPS System which is an end-stage revision knee product that allows surgeons to reconstruct severe soft tissue and bony defects. The diaphyseal sleeve is intended to enhance the fit and fill of the diaphyseal femoral canal with femoral and tibial replacements.

RECOMMENDATION: On Jan. 4, 2013, DePuy issued an Urgent Medical Device Recall informing hospitals and surgeons of the problem and to immediately stop distributing or using the recalled lots. If a medical facility has the affected product in stock, it should be returned to DePuy.

DePuy is not recommending revision or additional follow up in the absence of symptoms of patients with this implanted device. However, DePuy is encouraging surgeons to communicate with patients who received these implants and discuss the risks of the implant fracture and the method for detecting implant failure if the patient begins experiencing symptoms.

Here is a partial list of the conditions being investigated:

    Infections
    Pain
    Possible loss of limb
    Decreased range of motion
    Lengthening or shortening of leg
    Dislocations
    Subluxation
    Flexion contracture
    Bone fractures
    Shifts in the positioning of the device
    Loosening, bending, cracking, fracture, deformation or wear of one or more of the components

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm340740.htm