FDA Recall D-1277-2014
Deseo Rebajar · Fajardo, PR
Class I — life-threatening Terminated 1273 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
Adipotrim XT, New Powerful Formula, 30 rapid release capsules per bottle, Dietary Supplement, www.adipotrim.com.
Reason for recall
Marketed Without an Approved NDA/ANDA: FDA lab results found undeclared API Fluoxetine in this dietary supplement.
Recall record
- Recall number
D-1277-2014- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Distribution
- Nationwide and Puerto Rico
- Recall initiated
- 2013-11-07
- Classified by FDA Center
- 2014-04-25
- FDA published
- 2014-05-07
- Terminated
- 2017-05-03
- Recalling firm
- Deseo Rebajar
- Firm location
- Fajardo, PR