D-1351-2014 Class I Terminated
FDA drug recall D-1351-2014 was initiated by Deseo Rebajar on December 23, 2013 and is designated Class I. Reason for recall: Marketed Without an Approved NDA/ANDA: Undeclared sibutramine and phenolphthalein in Burn 7 dietary supplement The recall status is terminated (terminated May 3, 2017). Affected quantity: 120 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- June 4, 2014
- Initiation Date
- December 23, 2013
- Termination Date
- May 3, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 120 bottles
Product Description
Burn 7 Capsules, supplied in 30 capsules bottle
Reason for Recall
Marketed Without an Approved NDA/ANDA: Undeclared sibutramine and phenolphthalein in Burn 7 dietary supplement
Distribution Pattern
Puerto Rico only
Code Information
MFD: 07.18.2013, EXP: 07.17.2015