Product Recall: MyNicNaxs.com Product Recall: MyNicNaxs.com

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Product Recall: MyNicNaxs.com

MyNicNaxs, LLC, Deltona, FL is voluntarily recalling all lots of dietary supplements distributed nationwide to consumers and stores. All lots means every bottle that went out of their warehouse, of every product they were selling.

Unfortunately, they are not the first company who needed to recall weight loss and sexual enhancement products. These niches seem to be rife with undeclared, misleading, and plain dangerous pills. Dozens of weight-loss and immune-system supplements on the market are illegally labeled and lack the recommended type of scientific evidence to back up their purported health claims.

Cautionary Tale

MyNicNaxs, LLC, Deltona, FL, is- or was- a company selling both dietary supplements for weight loss and sexual enhancement. Unfortunately, the dietary supplement (or “chinese medicine”) was  a misleading name for products that contained undeclared active pharmaceutical ingredients.

Drugs, in other words.

The FDA went to court to complain. First, they alleged that certain MyNicNaxs products are drugs under the FD&C Act because they are intended to cure, mitigate, treat or prevent disease.

Second, the drugs were misbranded because their labeling was false and misleading in that it didn’t  declare certain active pharmaceutical ingredients. The labeling failed to bear adequate directions for use, and/or the drugs are dangerous to health when used as recommended in the labeling.

The following permanent injuction required the defendants to stop distributing any unapproved new drugs or misbranded drugs. They were prohibited from receiving, manufacturing, holding and distributing any drugs or dietary supplements until the FDA puts out a written notification that they are in compliance of the FD&C Act and its regulations, and that they may resume operations.

The MyNicNax website is down, but the pinterest account is still up with photos of the products and promotional photos.

Harmful Substances

The FDA discovered the presence of Sildenafil, Sibutramine, Diclofenac and/or Phenolphthalein in the dietary supplements. This rendered the supplements as an unapproved drug for which safety and efficacy have not been established.

These products were distributed from January 2013, to December 2017, though the website http://www.mynicnaxs.com.

The undeclared drugs can cause serious health risk. A)Some of them are cancerous, and B)Taking drugs unknowingly can interfere and interact with other drugs the person is taking. Or can expose the consumer to a drug that is harmful or dangerous in their particular situation… a drug they would never take if they knew it was in the magic pill.

The following drugs were detected in the products:

Sibutramine is the active pharmaceutical ingredient in Meridia, a new drug approved by FDA for marketing in 1997 for prescription treatment of obesity and, subsequently, withdrawn from the U.S. market on December 21, 2010, after clinical data indicated Sibutramine poses an increased risk of heart attack and stroke.

Phenolphthalein is a known carcinogen (cancer causing agent) It was once an ingredient used in over-the-counter laxatives. It is no longer approved for marketing in the United States.

Sildenafil is the active pharmaceutical ingredient in Viagra (PDE-5 inhibitor), a drug approved by FDA for the treatment of erectile dysfunction. PDE-5 inhibitors may interact with nitrates found in some prescription drugs (such as nitroglycerin). PDE-5 inhibitors can lower blood pressure to dangerous levels.

Diclofenac is a non-steroidal anti-inflammatory drugs (NSAIDs) found in FDA-approved drugs that are used to treat pain and inflammation associated with several conditions. NSAIDs could lead to serious GI trouble, like bleeding, ulceration, and fatal perforation of the stomach and intestines.

Patients who are already taking medication that could cause bleeding may increase their risk for bleeding significantly.

This is a list of all the website products, as listed on the FDA website: 26 products in all that did not disclose drugs in the ingredient list on the bottle.

Product Description API Found in FDA Lab Results
Platinum Maximum Strength Blue Pill Version;
30 capsules; 500mg each
Sibutramine and Phenolphthalein
Platinum Maximum Strength Blue Pill Version;
30 capsules; 500mg each
Sibutramine and Phenolphthalein
Slimming Plus Advanced Weight Loss; 30
capsules; 500mg each
Sibutramine and Phenolphthalein
African Viagra – sexual performance
enhancement product; 4500mg x 2
Sildenafil
GINSENG – sexual performance enhancement
product; 300mg/tablet x 10 tablets
Sildenafi
African Superman – sexual performance
enhancement product; 2900mg x 8 tablets per
blister pack
Sildenafil
Old Chinese – sexual performance enhancement
product; 19800mg x 10 capsules
Sildenafil
Lean Extreme Max; 30 capsules; 400mg each Sibutramine
X-treme Beauty Slim; 30 capsules; 350mg each Sibutramine
African Superman – Top-Class Permanence
Tablet; 2900mg x 8 tablets
Sildenafil
Slim Evolution – 100% Natural Ingredients; 30
capsules; 350mg each
Diclofenac
Meizitang Strong Version capsules packed in a
non-flexible clear bottle with a green screw-on
top
Sibutramine
Magic Slim capsules packed in a non-flexible
white bottle with a white screw-on top
Sibutramine
Slim Xtreme capsules packed in a non-flexible
white bottle with a white screw-on top
Sibutramine
Meizi Evolution capsules were packed in a non-
flexible clear bottle with a blue screw-on top
Sibutramine
SlimEasy Herbs capsules packed in blister
packaging and placed in a white box with black
labeling
Sibutramine
Hokkaido – capsules packed in blister packaging
in pink box with black labeling
Phenolphthalein
Super Fat Burning Bomb capsules in blister
packs, packaged in a red box with black labeling
Sibutramine and Phenolphthalein
FRUTA Bio blister packs, packaged in a
yellow/green box with green labeling
Sibutramine and Phenolphthalein
JIANFEIJINDAN Activity Girl – blister packs,
packaged in a white/pink box with pink labeling
Sibutramine
Reduce Weight FRUTA PLANTA blister packs,
packaged in a yellow/green box with green
labeling
Phenolphthalein
Fat Loss Slimming Beauty – 30 capsules in
blister packs packaged in yellow/black box -500
mg
Sibutramine and Phenolphthalein
Fruta Planta -blister packs packaged in
yellow/green box with green labeling
Sibutramine and Phenolphthalein
Botanical Slimming – 100% Natural Soft gel; 30 soft gels; 650mg each packaged in a green bag with yellow and white lettering
Slim Body – Dietary Supplement;100% Herbal Slimming Formula; 30 capsules; 6x5x300mg blister packs, packaged in blue and red box

If you have bought any of these products, you are advised to immediately discontinue use.

There have been no reports of adverse effects so far. If you think you have experienced adverse effects, speak to your health care provider immediately. You should also report to the FDA MedWatch Adverse Event Reporting Program by filling out the online form, or sending the form by regular mail or fax.

For any questions regarding this recall, contact Mike Banner by phone 407-791-3597 or Chevonne Torres 386-337-8142, Monday to Friday, 09:00am-5:00 pm, Eastern Time.

 

 

 

I know I can count on you all to collect everything and do it safely.

You are a great company to work with. At our pharmaceutical production laboratory. We have gallons of leftover pharmaceutical waste that are a headache for our techs to deal with. I know I can count on you all to collect everything and do it safely. I’m pleased with the personal service.

M

Mitchell Adam

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