Dietary Supplements Recalled Due to Presence of Sildenafil
SOS Telecom Inc is voluntarily recalling dietary supplements that contain sildenafil.
SOS Telecom Inc is voluntarily recalling dietary supplements that contain sildenafil.
The presence of the PDE-5 inhibitor mean these supplements are unapproved drugs. Sildenafil was not listed on the product labels.
“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,” the FDA said in a statement. “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.”
The affected products are:
· Tiger-X (Lot No: 9236999; Best use by: 12/16/2016): 1 capsules per pack / 24 single packs per box.
· Ninja-X (Lot: 7920888; Best Use by: 6/31/2018) 1 capsules per pack / 24 single packs per box.
· Ginseng Power-X (Lot: 7788965; Best use by: 10/15/2018) 1 capsules per pack / 24 single packs per box.
· Super Samurai-X (Lot No: 7920499; Best use by: 10/15/2016) 1 capsules per pack / 24 single packs per box.
The products were marketed for male sexual enhancement.
SOS Telecom Inc is notifying customers through email and a press release.
Anyone in possession of these products should stop using them and arrange for a return of the products to: Attn: RECALL NOTICE SOS Telecom, Inc. 202-28 45th Ave., Bayside, NY 11361.
The FDA is asking individuals to report any adverse effects to its MedWatch Adverse Event Reporting program online.
