D-0910-2016 Class II Ongoing
FDA drug recall D-0910-2016 was initiated by Invisiblu International LLC on March 31, 2016 and is designated Class II. Reason for recall: Marketed Without An Approved NDA/ANDA: Contains an unapproved drug, ligandrol LGD-4033 The recall status is ongoing. Affected quantity: 3,319 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- June 8, 2016
- Initiation Date
- March 31, 2016
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,319 bottles
Product Description
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 Pattern
Nationwide and Brazil.
Code Information
Lot # 21511166, Exp 11/18