Tiger-X Dietary Supplement Recalled for Undeclared Sildenafil
SOS Telecom Inc. is recalling Tiger-X dietary supplements because FDA testing found undeclared sildenafil or analogs. The product was marketed without an approved NDA or ANDA.
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 mandates a severity score of 5 according to the rubric.
Plain-English summary
SOS Telecom Inc. is recalling Tiger-X, 1200 mg, 1 capsule per pack, 24 single packs per box. The product was distributed in New York. The recall is due to FDA sample analyses that revealed the presence of undeclared sildenafil and/or its analogs in products marketed as dietary supplements.
The agency classified this recall as Class I. The product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). The specific lot number is 9236999, and the best use by date is 12/16/2016.
Consumers who have purchased this product should stop using it and contact the recalling firm for further instructions.
The recalled product
- Product
- Tiger-X, 1200 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 No: 9236999
- Best use by: 12/16/2016
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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