CLASS II ONGOING Drug recall · Reported 23 Dec 2020 · FDA Enforcement Report
High Dose B12, 10 MG/ML vial recalled by Advanced Nutriceuticals
Advanced Nutriceuticals is recalling High Dose B12, 10 MG/ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, distributed in 7 states. The recall was initiated on 30 Nov 2020 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0142-2021
- FDA event ID
- 86799
- Recalling firm
- Advanced Nutriceuticals, Indianapolis, IN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 30 Nov 2020
- FDA classified
- 11 Dec 2020
- Reported
- 23 Dec 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 30 Nov 2020 | Recall initiated by company | |
| 11 Dec 2020 | Classified by FDA | +11 days |
| 23 Dec 2020 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
HIGH DOSE B12, 10 MG/ML, 10 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Where it was distributed
CA, CO, FL, IN, KY, OH, TX
Questions about this recall
Is High Dose B12, 10 MG/ML vial, The Guyer Institute of Molecular Medicine, Indianapolis recalled?
Yes. Advanced Nutriceuticals recalled High Dose B12, 10 MG/ML vial, The Guyer Institute of Molecular Medicine, Indianapolis on 30 Nov 2020. The recall is Class II and its status is Ongoing. Recall number D-0142-2021.
Why was it recalled?
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Which lots are affected?
Lot #1029202007, Exp 12/29/20
Where was it sold?
CA, CO, FL, IN, KY, OH, TX
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Advanced Nutriceuticals
All 17| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | PT-141, 10 MG/ML vial, The Guyer Institute of Molecular recalled | Advanced Nutriceuticals | Sterility | 7 states |
| Drug | CLASS II | Ipamorelin, 2000 MCG/ML vial recalled by Advanced Nutriceuticals | Advanced Nutriceuticals | Sterility | 7 states |
| Drug | CLASS II | Nandrolone, 200 MCG/ML, The Guyer Institute of Molecular recalled | Advanced Nutriceuticals | Sterility | 7 states |
| Drug | CLASS II | DSIP, 1000 MCG/ML vial, The Guyer Institute of Molecular recalled | Advanced Nutriceuticals | Sterility | 7 states |
| Drug | CLASS II | Pentosan Polysulfate, 300 MG/ML vial recalled by Advanced Nutriceuticals | Advanced Nutriceuticals | Sterility | 7 states |