FDA recall D-0910-2016

Invisiblu International LLC · Class II · drug

Product

LGD-Xtreme (ligandrol LGD-4033),capsules, 3 mg, 90-count bottle, Manufactured for Continuum Labs, Fort Lauderdale, FL

Reason for recall

Marketed Without An Approved NDA/ANDA: Contains an unapproved drug, ligandrol LGD-4033

Distribution

Nationwide and Brazil.

Key facts

Status
Ongoing
Initiation date
2016-03-31
Report date
2016-06-08
Voluntary/Mandated
Voluntary: Firm initiated
Location
Fort Lauderdale, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0910-2016