FDAFDA · Food and drugs·Recall number D-0142-2021
HIGH DOSE B12, 10 MG/ML, 10 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Published December 23, 2020 · Recall initiated: November 30, 2020
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Advanced Nutriceuticals, LLC
- Distributor
- CA, CO, FL, IN, KY, OH, TX
- Lot
- Lot #1029202007, Exp 12/29/20
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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