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Dietary Supplements Recalled Due to Presence of Sildenafil
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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.
