R Thomas Marketing recalling supplements for erectile dysfunction

R Thomas Marketing LLC is voluntarily recalling all lots of the following products to the consumer level:

• Black Ant: BIG BOX (20 small boxes / 4 capsules per box / 80 capsules total)
• Herb Viagra: BIG BOX (20 small boxes / 4 capsules per box / 80 capsules)
• Real Skill: BIG BOX (20 small boxes / 4 capsules per box / 80 capsules)
• Stree Overlord: BIG BOX (20 small boxes / 4 capsules per box / 80 capsules)
• Weekend Prince: BIG BOX (24 individual cards / 2 capsules per card / 48 capsules)
• African Black Ant: BIG BOX (8 small boxes / 6 capsules per box / 48 capsules)

These products were tested by the FDA and found to contain Sildenafil, a PDE-5 Inhibitor which is the active ingredient in an FDA-approved drug for erectile dysfunction (ED) making this tainted dietary supplement and unapproved drug. recalling supplements for erectile dysfunction is not listed on the product labels.

Risk Statement: This undeclared active ingredient poses a threat to consumers because Sildenafil may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Additionally, the product may cause side effects, such as headaches and flushing.

Out of an abundance of caution, R. Thomas Marketing is also recalling all lots of the following products previously sold at the consumer level because these products were sourced from the same vendors as the above-mentioned products and may have resulted in similar misbranding or the likelihood for misbranding to occur in the future:

• Bull: CASE (10 packs / 3 capsules per can / 30 capsules)
• Bulls Genital: CASE (10 Cans / 10 capsules per can / 100 capsules)
• Zhonghua Niu Bian: BIG BOX (6 small boxes / 6 capsules per box / 36 capsules)
• African Superman: BIG BOX (6 small boxes / 8 capsules per box / 48 capsules)
• Bigger Longer More Time More Sperms: BIG BOX (6 small boxes / 6 capsules per small box / 36 capsules)
• Black Ant King: BIG BOX (10 capsules / can / 12 cans per box / 120 capsules)
• Black Storm: SMALL BOX (6 capsules)
• Germany Niubian: BIG BOX (10 small boxes / 24 capsules per box / 240 capsules)
• Happy Passengers: BIG BOX (30 small boxes / 1 capsule per box / 30 capsules)
• Plant Vigra: BIG BOX / (18 cans / 6 capsules per can / 108 capsules)
• Hard Ten Days: BIG BOX (6 small boxes / 6 capsules per box / 36 capsules)
• Man King: BIG BOX (8 small boxes / 5 capsules per box / 40 capsules)
• Mojo Risen: BIG BOX (24 individual cards / 2 capsules per card/ 48 capsules)
• Night Man: SMALL BOX (6 capsules)
• Tiger King: BIG BOX (10 small bottles / 10 capsules per bottle / 100 capsules)
• Samurai-X: BIG BOX (24 individually wrapped capsules)
• Super Hard: BIG BOX (20 small boxes / 6 capsules per box / 120 capsules)
• Zhen Gong: BIG BOX (16 small boxes / 2 capsules per box / 32 capsules)

These products were marketed as dietary supplements for male sexual enhancement. The products are packaged in accordance with the respective identifiers listed above. All lots of the specified products sold by R Thomas Marketing via internet sales from September 2013 to present are included in this recall. The products were mainly sold through the following websites:

http://streeoverlord.us/
http://herbsviagra.com/
http://realskill.org/
http://www.blackantpills.us/
http://africanblackantpills.org/
http://africanblackantpills.com/
http://buddypills.com/
http://hobuck.com/
http://maleenhancers.net/
http://www.raffu.com/
http://africablackantking.net/

The products were sold through numerous websites (approximately 80), but these were the most commonly used. R Thomas Marketing is notifying its customers by issuing a press release and by direct notification via email.

Consumers and retailers that have any of these above mentioned products should stop using and/or distributing this product immediately and arrange return of the products to:

Attn: RECALL NOTICE
R Thomas Marketing LLC
20 Passaic St.
Trenton, NJ 08618

Consumers with questions regarding this voluntary recall can contact R Thomas Marketing LLC by email at rthomasmarketingbiz@gmail.com and/or calling at 914-278-0212. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these drug products.

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.

• Complete and submit the report online: www.fda.gov/medwatch/report.htm
• Regular Mail or FAX: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request reporting form, then complete and return to the address on the pre-addresses form, or submit by fax to 1-800-FDA-0178.

This recall and market action are being conducted with the knowledge of the U.S. Food and Drug Administration.

13 Dietary Supplements Recalled Due to Undeclared Salicylic Acid

Novacare, LLC of Murray, Utah is voluntarily recalling all lots of the following dietary supplements to the consumer level:

Name*	Brand Name	Quantity	UPC	Dates of Manufacture
Thin & Slim	Fataway Ultimate Stack	120 capsules	853002003025	2/21/2011- 3/16/2011
ThermoFX	ThermoFX<	90 capsules	793573902665	4/5/2011
Thin and Slim	MaxOut Body	60 capsules	N/A	10/24/2011- 2/11/2014
Metabolic Accelerator	Metabolic Accelerator	120 capsules	637687114593	2/23/2011- 3/18/2013
Thin and Slim	Burn Fat Now>	90 capsules	N/A	10/29/2011- 10/29/2014
Thin and Slim	Thermogenic Fat Burner	90 capsules	020025500095	10/29/2011- 10/29/2014
TruTrim		Bulk		11/30/2011
Thin and Slim Naturally AM	Thin and Slim Naturally	90 capsules	637687019003	10/29/2011- 10/29/2014
Thin and Slim	Extreme Stack	90 capsules	637687019133	1/30/2012, 3/20/2012
Xcellerator		Bulk		10/27/2011- 3/26/2012
Asia Black	Asia Black	100 capsules	859613274229	5/19/2011- 5/13/2014
Black Widow	Black Widow 25	100 capsules	859613252258	1/25/2011- 8/10/2014
Methyldrene	Methyldrene Original 25	100 capsules	859613638496	1/19/2011- 6/28/2013

* - Pictures of the product labels are included herewith for easier identification.

Sample analysis by the FDA has revealed that these products contain the undeclared drug ingredient salicylic acid making these unapproved new drugs.

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 is notifying its distributors and customers by certified mail and is arranging for return of all recalled product. Consumers/distributors/retailers that have the aforementioned products that are being recalled should stop using, distributing, or selling them and return them to:

Novacare, LLC

Returns Dept.: MS# 2000

913 West 2900 South

Salt Lake City, UT 84119

Consumers with questions regarding this recall can contact Novacare, LLC directly at (801) 261-2252, Monday through Friday from 10:00 am – 4:00 pm MST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking any of the aforementioned products.

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.

• Complete and submit the report Online:www.fda.gov/medwatch/report.htm

Health News: FDA:17 Dietary supplements contain illegal ingredient ♦ Noroviruses spread several meters by air: ♦ New cellular response to radiation exposure

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Noroviruses spread several meters by air: Noroviruses, a group of viruses responsible for over 50 percent of global gastroenteritis cases, can spread by air up to several meters from an infected person. The discovery suggests that measures applied in hospitals during gastroenteritis outbreaks may be insufficient..

Engineering new blood vessels in people is one step closer to reality  Scientists moved a step closer toward coaxing the body into producing its own replacement blood vessels after discovering that suppressing parts of the innate immune system may raise the chances of a tissue engineered vascular graft success.

New cellular response to radiation exposure: Must we reconsider the risks of low doses? Almost the entire human genome is transcribed into RNA, but only a fraction of this is actually used to produce protein. The function of the majority of the RNA, the so-called 'non-coding transcriptome' remains an enigma. Some non-coding RNA families have been recognized through their shared structural features.

Impaired sleep linked to lower pain tolerance People with insomnia and other sleep problems have increased sensitivity to pain. The effect on pain tolerance appears strongest in people who suffer from both insomnia and chronic pain, who may benefit from treatments targeting both conditions.

Supplements Recalled Because of Undeclared Drug Ingredients

Detox Transforms Health and Nutrition, Garner, NC announced it is conducting a voluntary recall of the following dietary supplements, to the consumer level, because they contain undeclared drug ingredients making them unapproved drugs.suppliments

Product Name	Bottle Color	Label	# Capsules	UPC	Lot	Expiration
EDGE Amplified Weight Release	White	Purple label	60	852175004174	ALL
iNDiGO	White	Dark blue label	60	852175004044	000034	4/10/2017
AMPD Gold Bee Pollen	White	Black label	60	852175004181	ALL
BtRim Max	White	Dark Red label	60	852175004068	00002	4/27/2017
iNSANE Bee Pollen	White	Bright Red label	60	852175004082	0000:02	6/20/2017

FDA analysis found iNDiGO and BtRim Max to contain undeclared phenolphthalein. The health risks of phenolphthalein could include potentially serious gastrointestinal disturbances, irregular heartbeat, and cancer with long-term use. FDA analysis found EDGE Amplified Weight Release and iNSANE Bee Pollen to contain undeclared phenolphthalein and fluoxetine. In addition to the potential adverse health consequences for phenolphthalein, the concomitant use of fluoxetine with other medications such as MAO-Inhibitors and serotonin precursors (such as tryptophans) is either contraindicated or is not recommended.

Fluoxetine is an SSRI with potentially life threatening side effects that is given to patients to treat depression, anxiety, panic attacks, obsessive-compulsive disorder, or bulimia. Even when taken as prescribed, fluoxetine has been associated with serious side effects including suicidal thinking, abnormal bleeding, and seizures. Thus, any adverse reaction that is possible with fluoxetine is possible with the fluoxetine containing dietary supplement product.

In patients on other medications for common conditions (aspirin, ibuprofen, or other drugs for depression, anxiety, bipolar illness, blood clots, chemotherapy, heart conditions, and psychosis), ventricular arrhythmia or sudden death can occur with concomitant use of fluoxetine. FDA analysis found AMPD Gold Bee Pollen to contain undeclared sildenafil which has the potential to interact with medications. Males taking nitrates are at risk for life threatening hypotensive events. Certain medications such as ritonavir, ketoconazole, and itraconazole as well as consuming substantial amounts of alcohol can increase the effects of sildenafil.

The products were distributed nationwide via the internet and retail stores.

Detox Transforms has ceased distribution of the products as the company is working in close cooperation with the U.S. Food and Drug Administration (FDA) to fully resolve this issue. Detox Transforms is notifying its distributors and customers by email, telephone, and mail and is arranging for return of all recalled products. Consumers/distributors/retailers that have these products which are being recalled should stop use and return to place of purchase for a full refund.

Consumers with questions regarding this recall may contact Detox Transforms at 877-404-7873 or 919-341-9050 between the hours of 10am – 6pm (EST), Monday through Friday. 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 these of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online: www.fda.gov/medwatch/report.htm
• Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.