FDA Recall D-0139-2021
Advanced Nutriceuticals, LLC · Indianapolis, IN
Class II Ongoing 1991 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
Product
CEREBROLYSIN, 107.5 MG/ML, 10 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Reason for recall
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Recall record
- Recall number
D-0139-2021- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- CA, CO, FL, IN, KY, OH, TX
- Recall initiated
- 2020-11-30
- Classified by FDA Center
- 2020-12-11
- FDA published
- 2020-12-23
- Recalling firm
- Advanced Nutriceuticals, LLC
- Firm location
- Indianapolis, IN
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.