Ginseng Power-X Recalled for Undeclared Sildenafil
SOS Telecom Inc. is recalling Ginseng Power-X capsules because FDA testing found undeclared sildenafil or analogs.
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 Ginseng Power-X, 1800 mg, 1 capsule per pack, 24 single packs per box. The product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). The recall is limited to Lot 7788965 with a best use by date of 10/15/2018.
The FDA initiated this recall after sample analyses revealed the presence of undeclared sildenafil and/or its analogs in the products. Sildenafil is a prescription medication, and its presence in a product marketed as a dietary supplement is a safety concern.
The affected products were distributed in New York (NY). Consumers who have this product should stop using it and contact the recalling firm for further instructions.
The recalled product
- Product
- Ginseng Power-X , 1800 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: 7788965
- Best use by: 10/15/2018
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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