The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0142-2021·Announced 2020-12-23

High Dose B12 Injection Recalled for Sterility Assurance Concerns

Advanced Nutriceuticals is recalling High Dose B12 vials because production processes cannot assure sterility. The product was distributed in seven states.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a lack of assurance of sterility, which poses a risk of serious injury or death from infection, meeting the criteria for a Severe rating.

Plain-English summary

Advanced Nutriceuticals, LLC is recalling High Dose B12, 10 MG/ML, 10 ML vials. The recall is due to concerns with production processes that cannot assure the sterility of products intended to be sterile.

The affected product is identified by Lot #1029202007 and has an expiration date of 12/29/20. The product was distributed in California, Colorado, Florida, Indiana, Kentucky, Ohio, and Texas. The recall is classified as Class II by the FDA.

Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
HIGH DOSE B12, 10 MG/ML, 10 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Manufacturer
Advanced Nutriceuticals, LLC
Category
Drug — Injectable Medication
Hazard
Affected units
1

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot #1029202007
  • Exp 12/29/20

Distribution

Distributed in 7 states:

Part of a larger recall action

This product is one of 17 recalled by Advanced Nutriceuticals, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 17 products in this recall →

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