Agency classClass IIOur severity:Severe FDA (Drugs)·D-0137-2021·Announced 2020-12-23

Advanced Nutriceuticals Recalls B12 Injection Vials Due to Sterility Concerns

Advanced Nutriceuticals is recalling B12 for Injection 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, which corresponds to a Severe severity score under the rubric for significant injury or property damage reports or high-risk defects.

Plain-English summary

Advanced Nutriceuticals, LLC is recalling B12 for Injection, 2 MG/ML, 10 ML vials manufactured by The Guyer Institute of Molecular Medicine in Indianapolis, IN. 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 #1111202001 with an expiration date of 01/11/2021. The recall covers 1 vial per unit. Distribution was limited to California, Colorado, Florida, Indiana, Kentucky, Ohio, and Texas.

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

The recalled product

Product: B12 for Injection, 2 MG/ML, 10 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Manufacturer: Advanced Nutriceuticals, LLC
Category: Drug — Injectable
Hazard: sterility
infection
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 #1111202001
Exp 01/11/2021

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 →

Same manufacturer · Advanced Nutriceuticals, LLC

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