Showing posts with label sildenafil. Show all posts
Showing posts with label sildenafil. Show all posts

Sunday, January 10, 2016

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

Friday, December 25, 2015

APEXXX and OPAL male enhancement supplement recalled

Nuway Distributors llc is voluntarily recalling all lots of APEXXX tablets to the consumer level. FDA analysis found APEXXX to contain amounts of the PDE-5 Inhibitor, sildenafil, which is the active ingredient in an FDA-approved drug for erectile dysfunction (ED) making this tainted dietary supplement and unapproved drug.
Sildenafil is not listed on the product labels. Sildenafil may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels that may be life threatening. 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.
This product marketed as a dietary supplement for male sexual enhancement. APEXXX is packaged in a single blister pack containing 1 tablet. UPC 705105963617. All lots of APEXXX are included in this recall sold in 2014 to June 2015. APEXXX can be identified by the black packaging, it is a yellow diamond shaped tablet embosses with the wording "APEXXX" on it. APEXXX was sold in retail store located in Orlando, Florida for further sale in smoke shops, convenient stores and gas stations. APEXXX may also have been further sold online.
In an abundance of caution, Nuway Distributors llc is also removing all lots of OPAL tablets to the consumer level because this product is sourced from the same vendors as the APEXXX product. OPAL is packaged in a single blister pack containing 1 tablet, UPC 794504852400. OPAL can be identified by the black packaging, it is a black diamond-shaped tablet [note any embossing]. OPAL was also sold in a retail store located in Orlando, Florida for further sale in smoke shops, convenience stores and gas stations. OPAL may also have been further sold online.
Nuway Distributors llc is now notifying its customers by press release and is arranging for a return of all recalled and removed products.
Consumers and retailers that have APEXXX or OPAL should stop using and distributing this product immediately and arrange return of the products.
Consumers with questions regarding this voluntary recall can contact Nuway Distributors llc by email at nuwaydistributors@gmail.com and calling at 407-722-0061. 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.
"As Nuway Distributors llc receives this product from overseas in a sealed package, representing that it contains only lawful and legitimate ingredients, we are relying on the representations of the Food and Drug Administration that the public interest would best be served by voluntarily complying with their request to get the product off the shelves. Our goal is to protect the safety of the consumer," stated Nuway Distributors llc.