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.
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 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
- 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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