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.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. 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.
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