SOS Telecom, Inc. Recalls New Unapproved Drugs Marked as Dietary Supplements
- Company Announcement Date:
- May 10, 2016
- FDA Publish Date:
- April 04, 2019
- Product Type:
- Reason for Announcement:
Recall ReasonDevice & Drug Safety
- Company Name:
- SOS Telecom, Inc.
- Brand Name:
Brand Name(s)Tiger-X, Ninja-X, Ginseng Power-X, Super Samurai-X
- Product Description:
Product DescriptionMarketed as a dietary supplement
SOS Telecom, Inc. of Bayside, NY 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 this tainted dietary supplement and unapproved drug. 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.
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.
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 SOS Telecom, Inc. are included in this recall.
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.
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
Consumers with questions regarding this voluntary recall can contact SOS Telecom, Inc. by email at firstname.lastname@example.org and/or calling at 718-908-0206, Monday – Friday, 9:00 am to 10:30 am and 5:00 pm to 7:30 pm. 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 Complete and submit the report online: www.fda.gov/medwatch/report.htm
This recall and market action are being conducted with the knowledge of the U.S. Food and Drug Administration.
SOS Telecom, Inc.