FDAClass IIDecember 23, 2020

High Dose B12 recall: Sterility Concern

HIGH DOSE B12, 10 MG/ML, 10 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN

Why was High Dose B12 recalled?

Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #1029202007, Exp 12/29/20

Product
HIGH DOSE B12, 10 MG/ML, 10 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Recalling firm
Advanced Nutriceuticals, LLC
Quantity
1 vials
Distribution
CA, CO, FL, IN, KY, OH, TX
Recall date
December 23, 2020
Classification
Class II
Status
Ongoing
Agency
FDA (drug)
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