D-0473-2017 Class I Terminated
FDA drug recall D-0473-2017 was initiated by Jersey Shore Supplements, LLC on December 9, 2016 and is designated Class I. Reason for recall: Marketed without an approved NDA/ANDA: Product contains undeclared sibutramine and desmethylsibutramine. The recall status is terminated (terminated November 17, 2020). Affected quantity: 150 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- February 22, 2017
- Initiation Date
- December 9, 2016
- Termination Date
- November 17, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 150 bottles
Product Description
SLIMFIT X capsules, packaged in a 60-cont bottle
Reason for Recall
Marketed without an approved NDA/ANDA: Product contains undeclared sibutramine and desmethylsibutramine.
Distribution Pattern
New Jersey and Maryland.
Code Information
All lots and all expiration dates.