Friday, August 28, 2015

Novacare, LLC

Novacare, LLC Issues Voluntary Nationwide Recall of Dietary Supplements Due to Undeclared Salicylic Acid


Salicylic acid is acutely toxic, not recommended for oral use and is harmful if swallowed. Nausea, vomiting, gastrointestinal irritation, loss of hearing, sweating to severe reactions of blurred vision, mental confusion, cerebral edema and cardiorespiratory arrest which could be life-threatening may occur. Since the labeling does not state salicylic acid is contained it the product, individuals who are allergic, elderly, have a history of stomach ulcers or bleeding problems, consume ≥ 3 alcoholic drinks per day, or take concomitant medications containing salicylates are at higher risk for toxicity. No illnesses from these products have been reported to date.

These products are marketed as dietary supplements aiding in weight loss, produced in capsule form, and were sold in bottles. These products were distributed nationwide to distributors.

— Novacare, LLC of Murray, Utah is voluntarily recalling all lots of the following dietary supplements to the consumer level:
  • Thin & Slim
    •  - Fataway Ultimate Stack
    • - MaxOut Body
    • - Burn Fat Now
    • - Thermogenic Fat Burner
    • - Extreme Stack
    • - Thin and Slim Naturally AM
  • ThermoFX
  • Metabolic Accelerator
  • Xcellerator
  • Asia  Black
  • Black Widow 25
  • Methyldrene Original 25
  • TruTrim

Miracle Diet

The One Minute Miracle Inc. Issues Voluntary Nationwide Recall of MIRACLE DIET 30 Due to Presence of Undeclared Phenolphthalein & MIRACLE ROCK 48 Due to Presence of Undeclared Thiosildenafil


This voluntary recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

FOR IMMEDIATE RELEASE - August 27, 2015, North Miami Beach, Florida - The One Minute Miracle Inc. is voluntarily recalling one lot each of Miracle Diet 30, capsules and Miracle Rock 48.

Miracle Diet 30 has been found to contain undeclared phenolphthalein, phenolphthalein was an ingredient used in over-the counter laxatives but was removed from the market because of concerns of carcinogenicity. There is a reasonable probability that the health risks of long term phenolphthalein consumption could include serious gastrointestinal disturbances, irregular heartbeat, and cancer with long term use.




Miracle Diet 30 capsules is marketed as a dietary supplement to support appetite control and lose weight and is packaged in 30-count plastic bottles. 



The affected Miracle Diet 30 Lot Number 150416, Expiration 04/15/2018. Product was distributed via internet nationwide in the United States.

Thursday, August 20, 2015

Maxam Neutraceutics (James G. Cole, Inc.)

Court Ordered Product Recall


The United States District Court for the District of Oregon issued a product wide recall on all Maxam products. Citing James G. Cole Inc. for misbranding, adulterated and unapproved new drugs because certain claims about their effects had not been approved by the FDA.


Product list as provided by the FDA:

AD Nutritional Support for a Positive Outlook;
AFX Nutritional Support for Healthy Cellular Function;
ANANDA Nutritional Support for Emotional & Muscular Well-Being;
ANAVONE Nutritional Support for Healthy Stress Management;
ANACORT 5 Methyl 7 Methoxyisoflavone;
BCAA Branched Chain Amico Acids. Nutritional Support for Muscle Growth;
BIOGUARD Nutritional Support for Gastrointestinal Health;
B-MAX Nutritional Support for Endogenous B Vitamins;
CELLAFLEX Nutritional Support for Joints, Skin & Connective Tissue;
CO-Q10 Nutritional Support for Endogenous Co-Q10;
CREOCELL Nutritional Support for Endogenous Creatine Phosphokinase (CPK);
CYTOMUNE Nutritional Support for Healthy Immune Function;
C-60 Fullerine. Nutritional Support for Antioxidant Activity;
DEEP SLEEP; ENDOTROPIN;
FGF Fibroblast Growth Factor. Nutritional Support for Endogenous;
FGF;
GTF;
HCG Nutritional Support for Endogeous HCG;
HIGH CHI;
H-PLUS H-Plus Hydrogen. Nutritional Support for Health Cellular Antioxidant Activity; KETOPLEX Nutritional Support for Women's Hormonal Health;
LIV Nutritional Support for Liver Health;
MAXATROPIN Nutritional Support for Hormonal Health in Men & Women;
MYOTROPIN Myostatin Inhibitor. Nutritional Support for Healthy Muscle Regeration;
NADH Nutrional support for Healthy Mitochondrial Function;
NATURAL PASSION;
NERVEX Nutritional Support for Healthy Nerve Function;
NEUROGEN Nutritional Support for Healthy Brain Function;
OSTEOREN Nutritional Support for Health Teeth & Bones;
OXYCHARGE Nutritional Support for Aerobic Metabolism & Endurance;
OXYTOCIN Nutritional Support for Endogenous Oxytocin;
PC3 Nutritional Support for Toxin & Waste Elimination 3 Ways;
PCA Nutritional Support for Natural Toxin & Waste Elimination;
PCR;
PHP Paleolithic Human Probiotics. Probiotic & Post Biotic;
PINEAL Nutritional Support for Pineal Health;
SAMe Nutritional Support for Endogenous SAMe;
SERENITY;
TELONGMERASE Nutritional Support for Telomere Health;
TRANQUILITY Nutritional Support for Relaxation;
TRP Nutritional Support for Healthy Thyroid Function;
XOMATROPIN Nutritional Support for Endogenous HGH;

In addition: ALL ASN products:

The ASN products are in capsule or powdered form and bear the ASN label.

AFINITY WHEY PROTEIN;
DHEA;
HUMAGRO Homeopathic Growth Hormone 4c;
PHYTOBOL;
TESTRX;
TRIBESTRONE II;


source

View the 2010 Warning Letter from the FDA below:

Thursday, August 13, 2015

Pharmaceutical Company gest hit when Celeb posts Instagram pics!

Not weight loss related, but still note worthy.... 

Famous celeb Kim Kardashian posted pics
of FDA approved anti-nausea and vomiting meds.




picture found here:

What the FDA has to say 

"" The social media post is false or misleading in that it presents efficacy claims for DICLEGIS, but fails to communicate any risk information associated with its use and it omits material facts.""



Read more here: 

Thursday, August 6, 2015

Achieving Zero Contains Hidden Drug Ingredient

[8-6-2015] The Food and Drug Administration (FDA) is advising consumers not to purchase or use Achieving Zero, a product promoted and sold for weight loss on various websites such as www.amazon.com.Image of Achieving Zero 
 
FDA laboratory analysis confirmed that Achieving Zero contains sibutramine. Sibutramine is a controlled substance that was removed from the market in October 2010 for safety reasons. The product poses a threat to consumers because 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. This product may also interact, in life-threatening ways, with other medications a consumer may be taking.
 
Health care professionals and patients are encouraged to report adverse events or side effects related to the use of this product to FDA's MedWatch Safety Information and Adverse Event Reporting Program:
 
Note: This notification is to inform the public of a growing trend of dietary supplements or conventional foods with hidden drugs and chemicals. These products are typically promoted for sexual enhancement, weight loss, and body building and are often represented as being “all natural.” FDA is unable to test and identify all products marketed as dietary supplements that have potentially harmful hidden ingredients. Consumers should exercise caution before purchasing any product in the above categories. 

reprinted from: http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/MedicationHealthFraud/ucm457441.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery