SLIMFIT X capsules, packaged in a 60-cont bottle
FDA Recall #D-0473-2017 — Class I — December 9, 2016
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.
Recalling Firm
Jersey Shore Supplements, LLC — Bradley Beach, NJ
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
Product Quantity
150 bottles
Distribution
New Jersey and Maryland.
Code Information
All lots and all expiration dates.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated