Tuesday, December 29, 2015

Arkansas Compounding Pharmacy Recalls Sterile Products

Flagged in recent inspections for apparent safety lapses, a compounding pharmacy in Conway, Arkansas, is voluntarily recalling all lots of its sterile products for humans and animals that were distributed between March 14, 2015, and September 9, 2015, the US Food and Drug Administration (FDA) announced today.
The pharmacy, US Compounding, is taking the action "due to (FDA) concern over a lack of sterility assurance," the company said in a news release posted on the agency's website.
The recalled products for humans — the vast majority are injectables — include testosterone, corticosteroids, glycopyrrolate, fentanyl, and the vasodilator alprostadil. Also on the list are topical ophthalmic drugs. The products were distributed to patients and healthcare providers alike.

http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm339771.htm

Monday, December 28, 2015

BeeXtreme Recalls All Lots of 3 Dietary Supplements

BeeXtreme LLC announced a recall of all lots of La' Trim Plus, Jenesis, and Oasis products from the market. A recent analysis by the Food and Drug Administration (FDA) had shown undeclared sibutramine and phenolphthalein in the Company's 3 dietary supplements.

Sibutramine is a medication that assists with weight-loss by altering neurotransmitters within the brain. Neurotransmitters are chemicals that are produced and released by nerves in order to communicate with other nerves. Released neurotransmitters may attach to other nerves or they may be taken up again by the nerves that release them, a process termed reuptake.


Monday, December 14, 2015

Lipo Escultura Corp. Issues Nationwide Recall of Lipo Escultura Due to Undeclared Sibutramine and Diclofenac



From the FDA:

Lipo Escultura Corp. of Brooklyn, NY dba JAT Productos Naturales Corp., and JAT Natural Products Corp. are voluntarily recalling all Lipo Escultura within expiry to the consumer level. The Lipo Escultura capsules were tested by the U.S. Food and Drug Administration and have been found to contain two potentially harmful ingredients--sibutramine and diclofenac.
Risk Statement: Sibutramine is an appetite suppressant now a controlled substance that was removed from the market for safety reasons. Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke. Diclofenac is a non-steroidal anti-inflammatory drug (commonly referred to as NSAIDs). NSAIDS may cause increased risk of cardiovascular events, such as heart attack and stroked, as well as serious gastrointestinal damage, including bleeding, ulceration, and fatal perforation of the stomach and intestines.
The product is used as a weight loss dietary supplement and is packaged in a white plastic bottle with green and lime labeling with white capsules. Products were sold/distributed Nationwide by JAT Productos Naturales Corp. via internet sales on www.lipoesculturatreatment.com, through Lipo Escultura Corp. 888 Wyckoff Ave. Brooklyn, NY 11237, a retail store and 1360 Hancock Street, Brooklyn, NY 11237, a home office.
The recall was initiated after a consumer illness was reported to the FDA and it was discovered that the product labeling does not reveal the presence of sibutramine or diclofenac.

http://www.fda.gov/Safety/Recalls/ucm475550.htm

Legal: Florida Company Glades Drugs Recalls Multivitamins Recalled for High Vitamin D3




News out of Pahokee this past week. 

The FDA announces a  voluntary recall of compounded multivitamin capsules that have high amounts of Vitamin D3 (Cholecalciferol). The product was distributed nationwide by Glades Drugs in Pahokee, Florida. The FDA has received several reports of adverse reactions that may be associated with this recalled product.

From the FDA site: 
The U.S. Food and Drug Administration is alerting health care professionals and patients of a voluntary recall of compounded multivitamin capsules containing high amounts of Vitamin D3 (Cholecalciferol),  distributed nationwide by Glades Drugs in Pahokee, Florida. FDA has received reports of several adverse events potentially associated with these compounded capsules made by Glades Drugs. Consumption of this product may result in vitamin D toxicity, which may be severe and may lead to life-threatening outcomes if left untreated. Patients suffering adverse effects from high Vitamin D levels (Cholecalciferol) may not initially show symptoms. Therefore, patients who have received these compounded capsules should stop taking this medication and immediately seek medical attention.
BACKGROUND: Symptoms of short-term vitamin D toxicity are due to high calcium levels (also known as hypercalcemia) and include confusion, increased urination, increased thirst, loss of appetite, vomiting, and muscle weakness. Acute hypercalcemia may intensify tendencies for heart arrhythmias and seizures and may increase the effects of certain heart drugs. Long-term toxicity may cause kidney failure, increase in calcium deposits in the blood and soft tissue, bone demineralization and pain. Patients with conditions such as liver disease or chronic kidney failure may be at increased risk for developing vitamin D toxicity.
RECOMMENDATION: Health care providers should quarantine and return any products subject to this recall to the company at: Glades Drugs, 109 S. Lake Ave., Pahokee, FL 33476.  Glades Drugs sent recall letters to patients, attempted to contact them by phone, and called prescribing physicians.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:


Lucy's Weight Loss Recalls Pink Bikini White Powder Capsules

Lucy's Weight Loss System has voluntarily recalled all lots of Pink Bikini White powder Capsules, 30 white (750MG per capsule) to the consumer level, as it has been found positive for diclofenac after FDA sampling and testing.

Pink Bikini is marketed as a weight loss dietary supplement and is packaged in clear bottle in white powder capsules. The product was distributed nationwide to consumers via PinkBikini.BigCartel.com and Waisted With Lucy Retail store.

Diclofenac is a nonsteroidal anti-inflammatory drug or NSAID. This medicine works by reducing substances in the body that cause pain and inflammation.

Diclofenac can increase the risk of fatal heart attack or stroke, especially if used long term or taken high doses, or if the user has heart disease.
For pregnant women, taking diclofenac during the last three months of pregnancy may harm the unborn baby.

This undeclared ingredient makes this product an unapproved new drug for which safety and efficacy have not been established.
Lucy's Weight Loss System has not received any reports of adverse events related to this recall.

http://www.rttnews.com/2589876/lucy-s-weight-loss-recalls-pink-bikini-white-powder-capsules.aspx

Sunday, December 13, 2015

Boston Scientific recalls Chariot Guiding Sheaths, citing complications

Boston Scientific Corp.’s Maple Grove campus is recalling its global supply of 7,000 Chariot Guiding Sheaths because parts of the device can break off during medical procedures and obstruct blood flow.
The company says doctors who used the Chariot sheath for minimally invasive procedures in the legs and arms should check back with those patients to make sure they’re doing OK.

More here: http://www.startribune.com/boston-scientific-recalls-chariot-guiding-sheaths-citing-complications/361361441/

Chipotle ecoli outbreak in Georgia, November 2015







Folks across Atlanta and beyond are asking about the supposed outbreak. Here is what we know: 


From the FDA:  
  • Three additional states have reported people infected with the outbreak strain of Shiga toxin-producing Escherichia coli O26 (STEC O26) since the last update, Illinois, Maryland, and Pennsylvania.
  • Fifty-two people infected with the outbreak strain of STEC O26 have now been reported from a total of nine states: California (3), Illinois (1), Maryland (1), Minnesota (2), New York (1), Ohio (3), Oregon (13), Pennsylvania (1), and Washington (27).
  • The epidemiologic evidence available at this time suggests that a common meal item or ingredient served at Chipotle Mexican Grill restaurants in several states is a likely source of this outbreak.
  • The investigation is still ongoing to determine what specific food is linked to illness.

As of December 4, 2015, the The CDC says that a total of 52 people infected with the outbreak strain of STEC O26 from a total of nine states: California (3), Illinois (1), Maryland (1), Minnesota (2), New York (1), Ohio (3), Oregon (13), Pennsylvania (1), and Washington (27). There have been 20 reported hospitalizations. 

Of the three most recent illnesses reported in November, only one ill person, whose illness started on November 10, reported eating at Chipotle Mexican Grill in the week before their illness began.



What are the Signs & Symptoms of E. coli O26?

  • People usually get sick from STEC (Shiga toxin-producing E. coli) 2-8 days (average of 3-4 days) after swallowing the organism (germ).
    • Most people infected with STEC develop diarrhea (often bloody) and abdominal cramps.
    • Most people recover within a week.
  • Some illnesses last longer and can be more severe, resulting in a type of kidney failure called hemolytic uremic syndrome (HUS).
    • HUS can occur in people of any age, but is most common in young children under 5 years, older adults, and people with weakened immune systems.
    • Symptoms of HUS can include fever, abdominal pain, pale skin tone, fatigue and irritability, small, unexplained bruises or bleeding from the nose and mouth, and decreased urination.
    • People who experience these symptoms should seek emergency medical care immediately.
  • STEC infection is usually diagnosed by testing of a stool sample for Shiga toxins.
    • Clinical laboratories are required in some states to send Shiga toxin-positive specimens from ill people to the state public health laboratory for identification of STEC and PulseNet testing.

http://www.fda.gov/Food/RecallsOutbreaksEmergencies/Outbreaks/ucm470410.htm





Wednesday, October 21, 2015

October 20, 2015 Tampa FL VW Recall Lawyers

There  is lots of talk across the south about VW and how it rigged its cars to test emissions lower.  Volkswagen has admitted to lying to government agencies and the people who bought or leased their diesel cars. By now, it's almost impossible to read about this on the Internet and read "class actions" filed. 

Is a class action case in Florida the best or only way to go. NO. So where does the anaylsis start? It starts with who claims to be first in line. 

VW has said they will pay for their illegal activity and false marketing claims. Who will be compensated?
  1. Federal and state governments. In similar cases, the mandatory penalties are paid first.
  2. VW Diesel Owners and Leasees. VW has already broken the trust their customers had in them. Prepare to stand in line.
Don’t forget about the VW Shareholders, who want to make sure their dividends stay intact. Bottom line: If you bought or leased a diesel-fueled 
Volkswagen JettaGolfBeetle,Passat, or Audi A3 sedan manufactured between 2009 and 2015, you need to be represented to fully and fairly recover losses from your devalued vehicle and other potential damages. The list of the named vehicles include:
  • VW Jetta TDI (model years 2009 – 2015)
  • VW Jetta SportWagen TDI (model years 2009-2014)
  • VW Golf TDI (model years 2010-2015)
  • VW Golf SportWagen TDI (model year 2015)
  • VW Beetle TDI and VW Beetle Convertible TDI (model years 2012-2015)
  • VW Passat TDI (model years 2012-2015)
  • Audi A3 TDI models using the 2.0L 4-cylinder TDI engine (model years 2010-2013)

    VW Diesel Owners -Florida Law Protects You

    The only way affected customers can help ensure they will be fully compensated for their losses is to sue Volkswagen.  What can one person claim - outside of a class action?
    • Overpayment of up to $6,000 for their vehicles.
    • Substantial loss of value in their vehicles.
    • Great difficulty in reselling their vehicles.
    • Potential loss of fuel efficiency and/or performance as the result of “fixing ” their vehicles.
  • contact us at 813-513-1381

Dietary Supplements Send 23,000 to ER Yearly

From Study: 

On the basis of 3667 cases, we estimated that 23,005 (95% confidence interval [CI], 18,611 to 27,398) emergency department visits per year were attributed to adverse events related to dietary supplements. These visits resulted in an estimated 2154 hospitalizations (95% CI, 1342 to 2967) annually. Such visits frequently involved young adults between the ages of 20 and 34 years (28.0% of visits; 95% CI, 25.1 to 30.8) and unsupervised children (21.2% of visits; 95% CI, 18.4 to 24.0). After the exclusion of unsupervised ingestion of dietary supplements by children, 65.9% (95% CI, 63.2 to 68.5) of emergency department visits for single-supplement–related adverse events involved herbal or complementary nutritional products; 31.8% (95% CI, 29.2 to 34.3) involved micronutrients. Herbal or complementary nutritional products for weight loss (25.5%; 95% CI, 23.1 to 27.9) and increased energy (10.0%; 95% CI, 8.0 to 11.9) were commonly implicated. Weight-loss or energy products caused 71.8% (95% CI, 67.6 to 76.1) of supplement-related adverse events involving palpitations, chest pain, or tachycardia, and 58.0% (95% CI, 52.2 to 63.7) involved persons 20 to 34 years of age. Among adults 65 years of age or older, choking or pill-induced dysphagia or globus caused 37.6% (95% CI, 29.1 to 46.2) of all emergency department visits for supplement-related adverse events; micronutrients were implicated in 83.1% (95% CI, 73.3 to 92.9) of these visits.

http://www.nejm.org/doi/full/10.1056/NEJMsa1504267

More than a quarter of the ER visits documented in the study involved young adults between the age of 20 and 34 years.

Sunday, October 04, 2015

Sunset Natural Products ordered to stop making or selling dietary supplement products

A Florida judge has barred a Florida dietary supplements maker from doing business until it cleans up its act.

The consent decree of permanent injunction was issued against Sunset Natural Products Inc. and its two owners, Teresa Martinez (a.k.a. Teresa Martinez-Arroyo) and Elsy Cruz, for manufacturing and distributing adulterated dietary supplements at its facility located in Miami, Florida.

The decree was entered by U.S. Magistrate Judge Edwin G. Torres for the U.S. District Court for the Southern District of Florida on the strength of a complaint filed by the U.S. Department of Justice, which alleged the company operates under conditions that do not meet the U.S. Food and Drug Administration’s current Good Manufacturing Practice (cGMP) requirements.

Under the terms of the consent decree, the company will not be allowed to manufacture or sell dietary supplement products until the FDA has determined that the business is in compliance with the Federal Food, Drug, and Cosmetic Act.

Novartis issues voluntary recall of ADHD drug manufactured in Georgia

Novartis  has issued a voluntary recall of more than 10,000 bottles of a drug used to treat attention deficit hyperactivity disorder (ADHD) that were manufactured at a plant in Georgia.
According to a FDA enforcement report, the Class III recall was for 10,767 bottles of prescription-only 10-milligram dexmethylphenidate HCI extended-release capsules that were manufactured by Alkermes Gainesville in Gainesville, GA. 

The reason cited for the recall was an "out of specification (above specification) result obtained at 6-hour dissolution time point during the 12-month stability testing."

http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=D-1430-2015&w=09232015&lang=eng

VW Recall Information

Trying to get to the full understanding of the VW scandal. VW's problems have continued to escalate in recent days, and even as prosecutors in both the U.S. and Germany look into the scandal, the automaker's top U.S. executive has been summoned to Capitol Hill, where he will testify before a congressional oversight panel on Oct. 8.

"The American people want to know why these devices were in place, how the decision was made to install them, and how they went undetected for so long. We will get them those answers," said Rep. Tim Murphy, the Pennsylvania Republican who serves as chairman of the Energy and Commerce Subcommittee on Oversight and Investigations.

Only Diesel Vehicles are Subject to the Recall & Subject to Possible Compensation for Owners/Lessees:

  • 2010 - 2015 Audi A3
  • 2012 - 2015 Volkswagen Beetle
  • 2012 - 2015 Volkswagen Beetle Convertible
  • 2010 - 2015 Volkswagen Golf
  • 2009 - 2015 Volkswagen Jetta
  • 2009 - 2014 Volkswagen Jetta SportWagen
  • 2012 - 2015 Volkswagen Passat
http://www.cnbc.com/2015/10/02/vw-emissions-cheating-scandal-heading-to-congress.html

Friday, October 02, 2015

Some Brain & Workout Supplements Contain Unapproved Drugs

The Study is here: 
http://onlinelibrary.wiley.com/doi/10.1002/dta.1853/full
Conclusion:

The newly developed UHPLC-PDA method facilitated the detection of vinpocetine and picamilon. This method exhibited excellent performance in terms of sensitivity and is a suitable method for rapid analysis of vinpocetine and picamilon in dietary supplements. The developed method was validated for all the parameters tested and successfully applied to the identification of vinpocetine in authenticated plant samples and dietary supplements.
As expected, vinpocetine was not detected in 2 authenticated samples of Vinca minor. Of the 23 vinpocetine dietary supplements tested, 17 contained vinpocetine and the quantity of vinpocetine in these supplements ranged from 0.3 to 32 mg per recommended daily serving. No vinpocetine was detected in 26% (6/23) of the sampled supplements. Vinpocetine was sold as if it were a constituent of lesser periwinkle in 13% (3/23) of the supplements. In summary, 39% (9/23) of the vinpocetine supplements were misbranded, and 74% (17/23) of vinpocetine supplement labels did not provide any information on the quantity of vinpocetine.
Of the 31 picamilon supplements tested, 30 contained picamilon and the quantity of picamilon ranged from 2.7 to 721.5 mg per maximum recommended daily serving. In the supplements providing a specific quantity of picamilon on the label, actual quantity of picamilon ranged from 99.6 to 157.9% of labelled quantity.


New York Advisory Position Regarding Juror Research and Social Media

Definitely worth a read:

TOPIC: Jury Research and Social Media
DIGEST: Attorneys may use social media websites for juror research as long as no communication occurs between the lawyer and the juror as a result of the research. Attorneys may not research jurors if the result of the research is that the juror will receive a communication. If an attorney unknowingly or inadvertently causes a communication with a juror, such conduct may run afoul of the Rules of Professional Conduct. The attorney must not use deception to gain access to a juror’s website or to obtain information, and third parties working for the benefit of or on behalf of an attorney must comport with all the same restrictions as the attorney. Should a lawyer learn of juror misconduct through otherwise permissible research of a juror’s social media activities, the lawyer must reveal the improper conduct to the court.
RULES: 3.5(a)(4); 3.5(a)(5); 3.5(d); 8.4
Read more here:http://www.nycbar.org/ethics/ethics-opinions-local/2012opinions/1479-formal-opinion-2012-02

Imported Dietary Supplements Recalled for Elevated Lead and Mercury Levels

Butala Emporium Inc., of Jackson Heights, NY, is voluntarily recalling 11 Ayurvedic (dietary) supplements (listed below) because the products were found to contain elevated lead and mercury levels which, if consumed, may cause health problems to consumers, particularly infants, small children, pregnant women, and those with underlying kidney disorders.
The products were distributed in NY through retail stores and to consumers as single-unit purchases via the firm’s Internet site within CA, CT, FL, HI, MA, NJ, OH, PA, VT, Washington, D.C., and PR.
Butala EmporiumThe recall was initiated after it was discovered that the products contain high levels of lead and mercury based on testing by the New York City Department of Health laboratory and the U.S. Food and Drug Administration (FDA). No complaints or illnesses have been received to date.
The concentration of lead exceeds the recommended daily lead exposure for children younger than 6 years of age and women of childbearing age and would likely be injurious to health. If a child or a pregnant woman is exposed to lead for a protracted period of time (e.g., weeks to months), permanent damage to the central nervous system, learning disorders, developmental defects, and other long-term health problems can occur. The problems that might occur are dependent on the duration and degree of exposure.

http://www.foodsafetynews.com/2015/09/imported-dietary-supplements-recalled-for-elevated-lead-and-mercury-levels/#.Vg6icvlViko

Sunday, August 23, 2015

Iowa Dietary Supplement Firm Shuts Down Under Consent Decree

U.S. District Judge Edward J. McManus for the U.S. District Court for the Northern District of Iowa entered a consent decree of permanent injunction against Iowa Select Herbs LLC, a manufacturer and distributor of drugs and dietary supplements, and its two co-owners, Gordon L. Freeman and Lois A. Dotterweich. The complaint, filed by the U.S. Department of Justice, sought a permanent injunction against the company and its owners for unlawfully manufacturing and distributing unapproved new drugs, misbranded drugs, adulterated dietary supplements and misbranded dietary supplements.  
 
The company and its owners marketed their products online athttp://stores.iowaselectherbs.com/ and through online marketplace websites, such as eBay, Amazon and buy.com. They also sold their products through a retail location in Cedar Rapids, Iowa. 
“The FDA works with companies to ensure their processes comply with the public health requirements in our laws and regulations,” said Melinda Plaisier, FDA associate commissioner for regulatory affairs. “But when a company refuses to comply, we will take aggressive enforcement action.”

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm458752.htm

FDA: CBD oil not a dietary supplement

A warning letter went to a seller of CBD Oil: 


This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address https://www.hempoilcare.com[1] in November 2014 and has determined that you take orders for several products that you claim contain cannabidiol (CBD), including but not limited to “Cibdex Hemp CBD Complex Drops,” “Cibaderm Hemp Salve,” “Dixie Botanicals Dew Drops Hemp Oil Supplement,” “Hemp Honey 21% Cannabidiol Oil,” “Hemp Honey CBD Vape Oil,” and “Hemp Pure Vape E-Drops,” which the website promotes for conditions that cause the products to be drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)], because the products are intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act. 
 
Examples of claims observed on your website https://www.hempoilcare.com that establish the intended use of your products include, but may not be limited to: 
 
On the “CBD oil – Pure Vape E-Drops 50mG” product webpage, https://www.hempoilcare.com/product/cbd-oil-pure-vape-drops/:
 
• “A literature review from 2009 recapped CBD’s documented capabilities as an . . . antipsychotic . . . vasorelaxant (lower blood pressure), antispasmodic, anti-ischemic, anti-cancer agent . . . antibacterial agent, anti-diabetic . . .”
 
On the “Hemp oil – Dixie Botanicals Dew Drops” product webpage, https://www.hempoilcare.com/product/hemp-oil-dixie-botanicals-dew-drops-100mg/:
 
• “EXPLORING SEVEN HEALTH BENEFITS OF CANNABIDIOL (CBD) . . . antipsychotic, anti-depressant . . . analgesic for rheumatoid arthritis . . . stimulating new bone growth and strengthening bones affected by osteoporosis . . . vasorelaxant for glaucoma . . . atheroscloerosis [sic], anti-ischemic (prevents plaque buildup in arteries)”
 
On the “CBD Oil” webpage, https://www.hempoilcare.com/cbd-oil/:
 
Under the heading, “Study: Cannabinoids Could Play A Role In Pancreatic Cancer Treatment”:
 
 “[A study] suggests that cannabinoids could help treat pancreatic adenocarcinoma – one of the most aggressive forms of cancer.”
 “[T]he administration of cannabinoids seemed to induce cancer cell apoptosis . . ..”
 
Under the heading, “CBD May Help Reduce Psychotic Symptoms of Schizophrenia”:
 
 “CBD has shown promise in preventing cancer from cigarette smoke, reducing heart damage from chemotherapy . . ..”
 “[Researchers] compared benefits of CBD and amisulpride, a potent antipsychotic, in 42 acute schizophrenia patients . . . . The researchers found that cannabidiol and amisulpride were both ‘safe and effective’ but they declared CBD superior . . . .”
 
It is clear from the claims above that your marketed products “Cibdex Hemp CBD Complex Drops,” “Cibaderm Hemp Salve,” “Dixie Botanicals Dew Drops Hemp Oil Supplement,” “Hemp Honey 21% Cannabidiol Oil,” “Hemp Honey CBD Vape Oil,” and “Hemp Pure Vape E-Drops” are drugs under section 201(g)(1)(B) of the Act because they are articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.
 
Your marketed products  “Cibdex Hemp CBD Complex Drops,” “Cibaderm Hemp Salve,” “Dixie Botanicals Dew Drops Hemp Oil Supplement,” “Hemp Honey 21% Cannabidiol Oil,” “Hemp Honey CBD Vape Oil,” and “Hemp Pure Vape E-Drops” are also “new drugs” under section 201(p) of the Act [21 U.S.C. § 321(p)] because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from the FDA, as described in section 505(a) of the Act [21 U.S.C. § 355(a)]; see also section 301(d) of the Act [21 U.S.C. § 331(d)].  FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective. 
 
Additionally, your marketed products  “Cibdex Hemp CBD Complex Drops,” “Cibaderm Hemp Salve,” “Dixie Botanicals Dew Drops Hemp Oil Supplement,” “Hemp Honey 21% Cannabidiol Oil,” “Hemp Honey CBD Vape Oil,” and “Hemp Pure Vape E-Drops” are misbranded within the meaning of section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)], because the labeling for these products fails to bear adequate directions for use. “Adequate directions for use” means directions under which a layman can use a drug safely and for the purposes for which it is intended [21 CFR § 201.5]. Your marketed products are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use this drug safely for its intended purposes. FDA-approved drugs which bear their FDA-approved labeling are exempt from the requirements that they bear adequate directions for use by a layperson [21 CFR §§ 201.100(c)(2) and 201.115].  Because the above-mentioned products lack FDA-approved applications, they are not exempt under 21 CFR §§ 201.100(c)(2) and 201.115.  For these reasons, these products are misbranded under section 502(f)(1) of the Act. The introduction or delivery for introduction of a misbranded drug into interstate commerce is a violation of section 301(a) of the Act [21 U.S.C. § 331(a)].
 
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your marketed products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law and FDA regulations.
 
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction. 
 
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction. Your response should be sent to:
 

Friday, July 31, 2015

Akttive High Performance Fat Burner Gold capsules recalled

783 bottles of Akttive High Performance Fat Burner Gold capsules weight loss supplements have been recalled. 

The product contains Sibutramine, desmethylsibutramine and Phenolphthalein. Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in October 2010 (due to increased risk of seizures, heart attacks, arrhythmia and strokes). Phenolphthalein is an ingredient previously used in over-the-counter laxatives, but because of concerns of carcinogenicity, it is not approved for marketing in the United States. These undeclared ingredients make the product an unapproved new drug for which safety and efficacy have not been established.

No illnesses or injuries have been reported to the company to date in connection with this product.

The product, marketed as a dietary supplement for weight loss, is packaged in aluminum bottles containing 30 gold capsules per bottle and labeled with Lot #000185004400, UPC 859189005005, Expiration 12/17.

Teva recalls Adrucil cancer drug for a second time

Teva has issued a voluntary recall for its intravenous cancer medicine Adrucil because of the potential presence of impurities.
As Philadelphia Business Journal reported, Teva recalled six lots of Adrucil because they may contain small amounts of silicone rubber pieces and fluorouracil crystals. In May, it recalled eight lots of the cancer medicine for the same reason.
No adverse events have been reported, but a company statement on the FDA website said “administration of an intravenous product with particulate matter has the potential to result in inflammation, allergic reactions, or blockage of blood vessels, leading to tissue death, which may be life-threatening if vital organs are affected.”

http://www.phillyvoice.com/teva-recalls-cancer-drug-second-time/

Bexco recalls DaVinci brand cribs

Bexco recalled about 11,700 DaVinci brand cribs in the United States and Canada because a metal bracket that connects the mattress support to the crib can break, creating an uneven sleeping surface or a gap. If this occurs, a baby can become entrapped in the crib, fall, or suffer lacerations from the broken metal bracket.

The recall includes DaVinci brand full-size cribs including the Reagan crib (model #M2801), the Emily crib, (model #M4791), the Jamie crib (model #M7301), and the Jenny Lind crib (model #M7391) manufactured from May 2012 through December 2012.

The company has received 10 reports of the mattress support brackets detaching. No injuries have been reported. For more information, go to the U.S. Consumer Product Safety Commission websit

Read more at http://www.philly.com/philly/blogs/healthy_kids/Bexco-recalls-DaVinci-brand-cribs.html#KRWQ2uiHVmzRbhE4.99

Monday, July 27, 2015

Bard IVC Filters and Potential Claims (July 2015)



Inferior vena cava (IVC) filters sold by Bard have been found to have a high failure rate in a study published in  the Archives of Internal Medicine.
IVC filters are implanted in patients to help prevent pulmonary embolism due to blood clots moving into the lungs. Patients who receive IVC filters such as the Bard Recovery and the G2 by Bard are often patients who are either unresponsive or unqualified due to other medical problems for anti-coagulant drugs.
The tiny vena cava filters are shaped similarly to a cone with legs that extend to catch blood clots. When these legs break off the pieces or the entire filter can migrate through the body to affect other body parts, perforate veins and even cause sudden death. The result of this study caused the FDA to take notice of the dangers involved in using IVC filters and issued a warning to physicians to monitor their patients and remove the filters once the risk of blood clotting has passed.  
The FDA issued a communication on this: 
Since 2005, the FDA has received 921 device adverse event reports involving IVC filters, of which 328 involved device migration, 146 involved embolizations (detachment of device components), 70 involved perforation of the IVC, and 56 involved filter fracture. Some of these events led to adverse clinical outcomes in patients. These types of events may be related to a retrievable filter remaining in the body for long periods of time, beyond the time when the risk of pulmonary embolism (PE) has subsided. 
The FDA is concerned that these retrievable IVC filters, intended for short-term placement, are not always removed once a patient’s risk for PE subsides. Known long term risks associated with IVC filters include but are not limited to lower limb deep vein thrombosis (DVT), filter fracture, filter migration, filter embolization and IVC perforation.
BACKGROUND: FDA reviewed the literature and is conducting quantitative decision analysis modeling to evaluate the change in the risk/benefit profile after retrievable IVC filter implantation over time. More information about FDA’s decision analysis model including risk/benefit implantation timeframe suggestions will be made available in an update to this communication as well as in a future publication in a peer-reviewed medical journal.

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm221707.htm

If you have been harmed by one of these products, call us at 866.373.1800 and ask for Ms. Cragin.

Xarelto Trials Set for 2016

Xarelto (rivaroxaban) is an anticoagulant (blood thinner) that prevents the formation of blood clots. Xarelto is used to prevent or treat a type of blood clot called deep vein thrombosis (DVT), which can lead to blood clots in the lungs (pulmonary embolism). A DVT can occur after certain types of surgery. It is also used in people with atrial fibrillation (a heart rhythm disorder) to lower the risk of stroke caused by a blood clot.
Now, more than 500 Xarelto lawsuits have been consolidated and are currently pending in federal district court in the Eastern District of Louisiana, and District Court Judge Fallon recently announced that the first bellwether trial is scheduled for August 1, 2016.
Besides the Xarelto trial set for August 1, 2016, the court also scheduled three more bellwether trials for August 22, September 12, and October 17, 2016. The first two trials will take place in the Eastern District of Louisiana, the third will be held in the Southern District of Texas, and the fourth is scheduled for the Southern District of Mississippi.
You can also find the Order regarding case-specific discovery here: 
http://www.laed.uscourts.gov/Xarelto/Orders/PTO14.pdf



Friday, June 19, 2015

Lumber Liquidators MDL Goes to Alexandria Virginia United States District Court Judge

Nationwide there is litigation involving Lumber Liquidators over claims of formaldehyde in several of the company's laminated flooring products. You can read more about the claims here.

Lawyers working on the cases asked to have the many different lawsuits centralized in one Court. Lumber Liquidators, based in Virginia asked to have all related cases sent to its home state. After hearing from various lawyers, the Judicial Panel on Multi District Litigation chose Alexandra Virginia. Here's the Order  


St. Mary's Hospital: Children's Deaths from Open Heart Surgeries at St. Mary's Hospital in West Palm Beach Prompt Federal Investigation

A West Palm Beach, Florida hospital, St. Mary’s Medical Center, is the subject of an investigation from The Centers for Medicare & Medicaid Services, as the hospital reportedly has one of the highest rates of death from open heart surgeries on children. Between the years 2011 and 2013, the mortality rate had risen as high as 12.5% among surgery recipients, according to reports.
CNN managed to obtain the data that the hospital is required to report to the state in order to calculate the 12.5% mortality rate.. This means that the death rate is nearly three times higher than the national average in hospitals around the country who perform heart surgery on infants and children. There is large concern among parents who have lost their children, as well as federal authorities, that the facility may be neglecting the basics of care, especially with regard to their Medicaid and Medicare patients.

The majority of patients who underwent open heart surgery at St. Mary’s Hospital were Medicaid patients. St. Mary’s Medical Center’s parent company, Tenet Healthcare, has declined to comment further on the claims that have been made about its program which opened in December 2011. This raises concerns over whether or not the hospital has been withholding its facts and figures.
CNN discovered after reviewing the information the hospital supplied to the State of Florida that 12.5% of the babies who underwent heart surgery since the progam’s beginning died. Heart surgery is often necessary to correct congenital heart defects. In centers which perform the highest number of surgeries to correct these defects, he mortality rate is very low regardless of the difficulty of the surgery.

According to physicians hired by the State of Florida to look into its program, St. Mary’s did not perform enough surgeries each year to become proficient. In fact, they did not perform even two surgeries per month over the life of the program. In fact, these investigators determined that St. Mary’s needed to stop all surgeries on infants immediately. St. Mary’s ignored the recommendations in this report and continued to operate on babies some of whom were injured or died.




Thursday, May 07, 2015

FDA Warns 14 Sports Supplement Companies Of Illegal DMBA (AMP Citrate)

BMPEA is a substance that does not meet the statutory definition of a dietary ingredient. The Federal Food, Drug, and Cosmetic Act defines a dietary ingredient as a vitamin; mineral; herb or other botanical; amino acid; dietary substance for use by man to supplement the diet by increasing the total dietary intake; or a concentrate, metabolite, constituent, extract, or combination of the preceding substances. BMPEA is none of these, rendering misbranded any products that declare BMPEA as a dietary supplement.
BMPEA is also known as:
  • ╬▓MePEA
  • R-beta-methylphenethylamine
  • R-beta-methylphenethylamine HCl
  • Beta-methylphenethylamine
  • ╬▓-methylphenylethylamine
  • 1-amino-2-phenylpropane 
  • 2-phenylpropan-1-amine 
  • 2-phenylpropylamine
  • alpha-benzylethylamine
  • 1-phenyl-1-methyl-2-aminoethane
  • beta-methylbenzeneethanamine
  • beta-phenylpropylamine
  • 2- phenyl-1-propanamine 
On April 23, 2015, the FDA issued warning letters to five companies regarding a total of eight products for which the product labeling lists BMPEA as a dietary ingredient. Two of the companies further identified the source of this stimulant as the botanical Acacia rigidula.
Under existing law, including the Dietary Supplement Health and Education Act passed by Congress in 1994, the FDA can take action to remove products from the market, but the agency must first establish that such products are adulterated (e.g., that the product is unsafe) or misbranded (e.g., that the labeling is false or misleading).
While BMPEA was listed as a dietary ingredient on the product labels, the substance does not meet the statutory definition of a dietary ingredient. The Federal Food, Drug, and Cosmetic Act defines a dietary ingredient as a vitamin; mineral; herb or other botanical; amino acid; dietary substance for use by man to supplement the diet by increasing the total dietary intake; or a concentrate, metabolite, constituent, extract, or combination of the preceding substances. BMPEA is none of these, rendering misbranded any products that declare BMPEA as a dietary supplement. Additionally, relating to the two companies that identified the botanical Acacia rigidula as the source of the BMPEA, research conducted by the FDA in 2013 established that BMPEA is not a constituent or extract of Acacia rigidula.  FDA considers these specific products to be misbranded for this reason, as well.
The companies have 15 business days from the date of receipt of the letter to communicate to the agency the specific steps they will take to bring their products into compliance with the law.


Saturday, April 25, 2015

Toxic Diet Pills Kill a 21 Year Old DNP

News of a tragic death this week involving a diet pill with DNP.

2,4-Dinitrophenol (2,4-DNP, DNP) is an organic compound with the formula HOC6H3(NO2)2. It is a yellow, crystalline solid that has a sweet, musty odor. It sublimes, is volatile with steam, and is soluble in most organic solvents as well as aqueous alkaline solutions. It is a precursor to other chemicals and is biochemically active, inhibiting energy (ATP) production in cells with mitochondria. DNP is considered an important environmental contaminant by the United States Environmental Protection Agency.

From various news sites:

The tablets that Parry is believed to have taken shortly before her death are being tested for a toxic substance called dinitrophenol or DNP, police said. Generally described as a yellow, powdery substance in medical literature, dinitrophenol has been used as a black market weight-loss drug for decades, authorities said.
The substance is illegal for use in a diet drug or supplement in the United States, according to a spokeswoman for the U.S. Food and Drug Administration.
Parry's mother, Fiona Parry, recounted the details leading up to her daughter's death on a post on the police department's website.
Fiona Parry said her daughter became ill after taking the diet pills but didn't initially realize the gravity of her situation. Even after taking herself to a local hospital, her daughter said she did not initially feel gravely ill, Fiona Parry recalled.
https://gma.yahoo.com/police-investigate-diet-pills-containing-dnp-womans-death-192949806.html