Dietary Supplement Recalled for Undeclared Fluoxetine and Lack of Approval
Deseo Rebajar is recalling Adipotrim XT dietary supplements because FDA testing found undeclared fluoxetine and the product was marketed without an approved NDA/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 minimum severity score of 5 according to the rubric.
Plain-English summary
Deseo Rebajar is recalling 1,146 bottles of Adipotrim XT, New Powerful Formula, 30 rapid release capsules per bottle. The product is a dietary supplement distributed nationwide and in Puerto Rico. The specific lot number is 052012, with an expiration date of 10/2015.
The recall was initiated because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). Additionally, FDA laboratory results detected the undeclared active pharmaceutical ingredient (API) fluoxetine in the dietary supplement.
Consumers who have purchased this product should stop using it and contact the recalling firm for further instructions.
The recalled product
- Product
- Adipotrim XT, New Powerful Formula, 30 rapid release capsules per bottle, Dietary Supplement, www.adipotrim.com.
- Manufacturer
- Deseo Rebajar
- Category
- Drug — Dietary Supplement
- Affected units
- 1,146
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 #: 052012
- Exp 10/2015
Distribution
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