MyNicNaxs Nutritional Supplement Recall [US]

US/Silver Spring: MyNicNaxs, LLC, a Deltona, Florida establishment, has recalled all lots of various Dietary Supplements due to suspected presence of Diclofenac, Phenolphthalein, Sibutramine and/or Sildenafil, all controlled substances and undeclared active pharmaceutical ingredients (“APIs”). The presence of Diclofenac, Phenolphthalein, Sibutramine and/or Sildenafil in the recalled Dietary Supplements renders them unapproved drugs for which safety and efficacy have not been established and, therefore, subject to recall. Due to their ingredients, these Supplements all pose serious health and safety hazards. FDA: http://ht.ly/zYCx30kVBsI

Direct link: https://www.fda.gov/Safety/Recalls/ucm613197.htm

Additional information:
The US Food and Drug Administration (“FDA”) reports the following over-the-counter (“OTC”) drugs are subject to this recall (in alphabetical order):

• African Superman – Sexual Performance Enhancement Product; 2900 mg by 8 tablets per blister pack, API found in FDA lab results: Sildenafil
• African Superman – Top-Class Permanence Tablet; 2900 mg by 8 tablets, API found in FDA lab results: Sildenafil
• African Viagra – Sexual Performance Enhancement Product; 4500 mg by 2, API found in FDA lab results: Sildenafil
• Botanical Slimming – 100% Natural Soft gel; 30 soft gels; 650 mg each packaged in a green bag with yellow and white lettering
• Fat Loss Slimming Beauty – 30 capsules in blister packs packaged in yellow/black box – 500 mg, API found in FDA lab results: Sibutramine and Phenolphthalein
• Fruta Bio blister packs, packaged in a yellow/green box with green labeling, API found in FDA lab results: Sibutramine and Phenolphthalein
• Fruta Planta -blister packs packaged in yellow/green box with green labeling, API found in FDA lab results: Sibutramine and Phenolphthalein
• Ginseng – sexual performance enhancement product; 300 mg/tablet by 10 tablets, API found in FDA lab results: Sildenafi
• Hokkaido – capsules packed in blister packaging in pink box with black labeling, API found in FDA lab results: Phenolphthalein
• Jianfeijindan Activity Girl – blister packs, packaged in a white/pink box with pink labeling, API found in FDA lab results: Sibutramine
• Lean Extreme Max; 30 capsules; 400 mg each, API found in FDA lab results: Sibutramine
• Magic Slim capsules packed in a non-flexible white bottle with a white screw-on top, API found in FDA lab results: Sibutramine
• Meizi Evolution capsules were packed in a non- flexible clear bottle with a blue screw-on top, API found in FDA lab results: Sibutramine
• Meizitang Strong Version capsules packed in a non-flexible clear bottle with a green screw-on top, API found in FDA lab results: Sibutramine
• Old Chinese – sexual performance enhancement product; 19800 mg by 10 capsules, API found in FDA lab results: Sildenafil
• Platinum Maximum Strength Blue Pill Version; 30 capsules; 500 mg each, API found in FDA lab results:, API found in FDA lab results: Sibutramine and Phenolphthalein
• Platinum Maximum Strength Blue Pill Version; 30 capsules; 500mg each, API found in FDA lab results: Sibutramine and Phenolphthalein
• Reduce Weight FRUTA PLANTA blister packs, packaged in a yellow/green box with green labeling, API found in FDA lab results: Phenolphthalein
• Slim Body – Dietary Supplement;100% Herbal Slimming Formula; 30 capsules; 6 by 5 by 300 mg blister packs, packaged in blue and red box
• Slim Evolution – 100% Natural Ingredients; 30 capsules; 350 mg each, API found in FDA lab results: Diclofenac
• Slim Xtreme capsules packed in a non-flexible white bottle with a white screw-on top, API found in FDA lab results: Sibutramine
• SlimEasy Herbs capsules packed in blister packaging and placed in a white box with black labeling, API found in FDA lab results: Sibutramine
• Slimming Plus Advanced Weight Loss; 30 capsules; 500 mg each, API found in FDA lab results: Sibutramine and Phenolphthalein
• Super Fat Burning Bomb capsules in blister packs, packaged in a red box with black labeling, API found in FDA lab results: Sibutramine and Phenolphthalein
• X-treme Beauty Slim; 30 capsules; 350 mg each, API found in FDA lab results: Sibutramine

==> No barcodes, UPCs, item numbers or other identification numbers were listed with this recall notification.

According to the FDA, medications containing the following APIs

• Diclofenac is a non-steroidal anti-inflammatory drug (NSAIDs) found in FDA-approved drugs that are used to treat pain and inflammation associated with several conditions. NSAIDs could lead to serious gastrointestinal (GI) adverse events such as 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.
• Phenolphthalein is a known Carcinogen (Cancer causing agent) that was once an ingredient used in over-the-counter laxatives but is no longer approved for marketing in the United States.
• 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.
• Sildenafil is the active pharmaceutical ingredient in Viagra (used as a PDE-5 inhibitor), a drug approved by FDA for the treatment of erectile dysfunction. PDE-5 inhibitors, however, may interact with nitrates found in some prescription drugs (such as Nitroglycerin) and can lower blood pressure to dangerous levels. People with diabetes, high blood pressure, high cholesterol or heart disease often take nitrates.

If you believe you have purchased or have in your possession any of the recalled Dietary Supplements, please do not consume them directly nor use them as an ingredient in another dish or preparation. Instead, return the Bella to the store where you purchased it for a full refund.

If you have any questions about this recall, please contact Mike Banner at MyNicNaxs LLC at  1-407-791-3597 or Chevonne Torres 1-386-337-8142, Monday to Friday from 9:00 AM to 5:00 PM Eastern Standard Time, Monday to Sunday.

==> To see other recalls and notifications caused by suspected contaminated, adulterated or mislabeled Diet Capsules, please search for “diet” using the Search Box at the top of this page.

==> To see other recalls and notifications caused by suspected Diclofenac contamination, please search for “Diclofenac” using the Search Box at the top of this page.

==> To see other recalls and notifications caused by suspected Phenolphthalein contamination, please search for “Phenolphthalein” using the Search Box at the top of this page.

==> To see other recalls and notifications caused by suspected Sibutramine contamination, please search for “Sibutramine” using the Search Box at the top of this page.

==> To see other recalls and notifications caused by suspected Sildenafil contamination, please search for “Sildenafil” using the Search Box at the top of this page.

==> To see other recalls and notifications for products manufactured, marketed and/or sold by MyNicNaxs, LLC, please search for “MyNicNaxs” using the Search Box at the top of this page.

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More information about this recall:
Recalls Direct RIN: 10388-2018
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