FDA Recall D-0910-2016
Invisiblu International LLC · Fort Lauderdale, FL
Class II Ongoing 3696 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
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
Recall record
- Recall number
D-0910-2016- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- Nationwide and Brazil.
- Recall initiated
- 2016-03-31
- Classified by FDA Center
- 2016-05-27
- FDA published
- 2016-06-08
- Recalling firm
- Invisiblu International LLC
- Firm location
- Fort Lauderdale, FL
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.