The Recall Desk
CriticalFDA (Drugs)·D-1351-2014·Announced 2014-06-04

Deseo Rebajar Recalls Burn 7 Capsules for Undeclared Sibutramine and Phenolphthalein

Deseo Rebajar is recalling Burn 7 Capsules because they contain undeclared sibutramine and phenolphthalein, which were not approved for use in dietary supplements.

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 indicates a reasonable probability that use of the product will cause serious adverse health consequences or death.

Plain-English summary

Deseo Rebajar is voluntarily recalling 120 bottles of Burn 7 Capsules, supplied in 30-capsule bottles. The product was distributed in Puerto Rico only. The recall is due to the presence of undeclared sibutramine and phenolphthalein in the dietary supplement.

The affected product has a manufacture date of 07.18.2013 and an expiration date of 07.17.2015. The recall was initiated because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

Consumers who have purchased this product should stop using it and contact the recalling firm for instructions on how to return the product or obtain a refund.

The recalled product

Product
Burn 7 Capsules, supplied in 30 capsules bottle
Manufacturer
Deseo Rebajar
Category
Drug — Dietary Supplement
Hazard
Affected units
120

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)

  • MFD: 07.18.2013
  • EXP: 07.17.2015

Distribution

Distributed in 1 state:

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