KABOOM Action Strips Recalled for Undeclared Sulfoaildenafil
Blue Square Market, Inc. is recalling KABOOM action strips because they contain undeclared sulfoaildenafil and were 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 per the rubric mandates a score of 5 (Critical) regardless of other factors.
Plain-English summary
Blue Square Market, Inc. is recalling 132 boxes of KABOOM action strips, Sexual Performance Strips, packaged in 6.4oz boxes containing 12 strips per box. The product is manufactured by Nutrology USA LLC. The recall covers all lots and the product was distributed nationwide.
The recall was initiated because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA) and contains undeclared sulfoaildenafil. Sulfoaildenafil is a pharmaceutical ingredient that requires FDA approval for marketing in the United States.
Consumers who have purchased these products should stop using them and contact the recalling firm for further instructions. The presence of undeclared pharmaceutical ingredients in dietary supplements or similar products can pose health risks, particularly for individuals with certain medical conditions or those taking other medications.
The recalled product
- Product
- KABOOM action strips, Sexual Performance Strips, packaged in 6.4oz box 12 strips per box, Nutrology USA LLC
- Manufacturer
- Blue Square Market, Inc.
- Category
- Drug — Dietary Supplement
- Affected units
- 132
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 (1)
- all lots
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Blue Square Market, 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 2 products in this recall →Related recalls
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