FDA Recalls Ninja-X Dietary Supplement for Undeclared Sildenafil
SOS Telecom Inc. is recalling Ninja-X dietary supplements because FDA analysis found undeclared sildenafil or its 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 Ninja-X, 4200 mg, 1 capsule per pack, 24 single packs per box. The recall was initiated because FDA sample analyses revealed the presence of undeclared sildenafil and/or its analogs in the products, which were marketed as dietary supplements.
The recalled products were distributed in New York. The specific lot number is 7920888, with a best use by date of 6/31/2018. The agency classification for this recall is Class I.
Consumers should stop using the recalled product and dispose of it or return it to the point of purchase. The product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).
The recalled product
- Product
- Ninja-X, 4200 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: 7920888
- Best Use by: 6/31/2018
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.
See all 4 products in this recall →Related recalls
Same manufacturer · SOS Telecom Inc.
See all →- CriticalDietary Supplement Recalled for Undeclared Sildenafil and Analogs
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