SOS Telecom Products: Recall - Undeclared Drug Ingredient

[Posted 05/13/2016]

AUDIENCE: Consumer

ISSUE: SOS Telecom, Inc. is voluntarily recalling all lots of the following products to the consumer level because these products were tested by the FDA and found to contain Sildenafil, and analogs of Sildenafil.  Sildenafil is a PDE-5 Inhibitor which is the active ingredient in an FDA-approved drug for erectile dysfunction (ED), making these products tainted dietary supplements and unapproved drugs. Sildenafil is not listed on the product labels.

• 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.

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.

BACKGROUND: These products were marketed as dietary supplements for male sexual enhancement. The products were sold through numerous retailers, including convenience stores and gas stations. SOS Telecom, Inc. is notifying its customers by issuing a press release and by direct notification via email.

RECOMMENDATION: 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 SOS Telecom, Inc. 202-28 45th Ave., Bayside, NY 11361

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report
• Download form 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

[05/10/2016 - Press Release - SOS Telecom, Inc.]