March 2016 FDA Recall Drug by Invisiblu International Llc
D-0910-2016 - Marketed Without An Approved NDA/ANDA

This Class II drug recall was voluntarily initiated by Invisiblu International Llc on March 31, 2016 for the product Drug. The FDA reported the reason for recall as marketed without an approved nda/anda. The product was distributed Nationwide and the recall is currently ongoing.

Recall Number: D-0910-2016

Reason for Recall
Marketed Without An Approved NDA/ANDA: Contains an unapproved drug, ligandrol LGD-4033
Initiated
03-31-2016
Reported
06-08-2016
Quantity
3,319 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73698
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Invisiblu International 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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide and Brazil.
Product Description About Product Description
Full technical description of the product.
LGD-Xtreme (ligandrol LGD-4033),capsules, 3 mg, 90-count bottle, Manufactured for Continuum Labs, Fort Lauderdale, FL

Batch or Lot Expiration Information

Lot# 21511166, Exp 11/18