Dietary Supplement Recalled for Undeclared Sildenafil and Analogs
SOS Telecom Inc. is recalling Super Samurai-X dietary supplements because FDA testing found undeclared sildenafil and/or its analogs.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classification is FDA Class I, which indicates a reasonable probability that use of or exposure to the violative product will cause serious adverse health consequences or death.
Plain-English summary
SOS Telecom Inc. is recalling Super Samurai-X, 1000 mg, 1 capsule per pack, 24 single packs per box. The product was marketed as a dietary supplement but was not approved by the FDA under a New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).
The recall was initiated after FDA sample analyses revealed the presence of undeclared sildenafil and/or its analogs in the product. Sildenafil is a prescription medication used to treat erectile dysfunction and pulmonary arterial hypertension. The presence of undeclared pharmaceutical ingredients in dietary supplements poses significant health risks, particularly for individuals taking other medications or with certain medical conditions.
The affected product is identified by Lot 7920499 and a best use by date of 10/15/2016. The product was distributed in New York (NY). Consumers who have purchased this product should stop using it immediately and contact the recalling firm or their healthcare provider for guidance on proper disposal or return.
The recalled product
- Product
- Super Samurai-X , 1000 mg, 1 capsule per pack , 24 single packs per box.
- Manufacturer
- SOS Telecom Inc.
- Category
- Drug — Dietary Supplement
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot: 7920499
- Best use by: 10/15/2016
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 4 recalled by SOS Telecom Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
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