December 2016 FDA Recall Drug by Jersey Shore Supplements, Llc
D-0473-2017 - Marketed without an approved NDA/ANDA

This Class I drug recall was voluntarily initiated by Jersey Shore Supplements, Llc on December 9, 2016 for the product Drug. The FDA reported the reason for recall as marketed without an approved nda/anda. The product was distributed in New Jersey and Maryland. and the recall is currently terminated.

Recall Number: D-0473-2017

Reason for Recall
Marketed without an approved NDA/ANDA: Product contains undeclared sibutramine and desmethylsibutramine.
Initiated
12-09-2016
Reported
02-22-2017
Quantity
150 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75929
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Jersey Shore Supplements, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
New Jersey and Maryland.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-17-2020
Product Description About Product Description
Full technical description of the product.
SLIMFIT X capsules, packaged in a 60-cont bottle

Batch or Lot Expiration Information

Lot# All lots and all expiration dates.