Agency classClass IIOur severity:Severe FDA (Drugs)·D-0136-2021·Announced 2020-12-23

FDA Recalls NANDROLONE Injections Due to Sterility Concerns

Advanced Nutriceuticals, LLC is recalling NANDROLONE 200 mcg/mL injections because production processes cannot assure sterility. The recall affects vials distributed to 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 source text identifies the recall as FDA Class II. According to the severity rubric, FDA Class II recalls are classified as Severe (Score 4), particularly when involving sterile products where sterility assurance is compromised.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a recall for NANDROLONE, 200 MCG/ML, 2 ML injections manufactured by Advanced Nutriceuticals, LLC. The product is associated with 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 consists of 2 vials per unit. Specific lots involved in the recall include Lot #1113202002 (Expiration 01/13/2021) and Lot #1102202005 (Expiration 12/08/2020). The FDA classifies this recall as Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The product was distributed in California, Colorado, Florida, Indiana, Kentucky, Ohio, and Texas. Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions on disposal or replacement.

The recalled product

Product: NANDROLONE, 200 MCG/ML, 2 ML, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Manufacturer: Advanced Nutriceuticals, LLC
Category: Drug — Injectable Sterile Product
Hazard: sterility-failure
infection-risk
Affected units: 2

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 (4)

Lot #1113202002
Exp 01/13/2021
Lot #1102202005
Exp 12/08/2020

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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Same hazard · sterility failure