Recalls / Class II
Class IID-0131-2021
Product
AOD-9604, 1200 MCG/ML, 5 ML vial The Guyer Institute of Molecular Medicine, Indianapolis, IN
- Affected lot / code info
- Lot #1029202003, Exp 11/29/2020; Lot #1110202002, Exp 12/10/2020; Lot #1112202001, Exp 12/12/2020
Why it was recalled
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Recalling firm
- Firm
- Advanced Nutriceuticals, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 836 E 86th St, N/A, Indianapolis, Indiana 46240-1806
Distribution
- Quantity
- 3 vials
- Distribution pattern
- CA, CO, FL, IN, KY, OH, TX
Timeline
- Recall initiated
- 2020-11-30
- FDA classified
- 2020-12-11
- Posted by FDA
- 2020-12-23
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0131-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.