B12 for Injection recalled over sterility concerns
- Recall date
- November 30, 2020
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Advanced Nutriceuticals, LLC recalls B12 for Injection, 2 MG/ML, 10 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
- Recall number
- D-0137-2021
- FDA classification
- Class II
- Brand / firm
- Advanced Nutriceuticals, LLC
- Sold / distributed
- CA, CO, FL, IN, KY, OH, TX
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.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
B12 for Injection, 2 MG/ML, 10 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
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