The Recall Desk
CriticalFDA (Drugs)·D-0297-2016·Announced 2015-11-25

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.

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 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
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 →

Same manufacturer · Blue Square Market, Inc.

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