Ginseng Power-X Recalled for Undeclared Sildenafil
SOS Telecom Inc. is recalling Ginseng Power-X capsules because FDA testing found undeclared sildenafil or 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 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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