The Recall Desk
SevereFDA (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.

What this means for you

Illness, injury, or structural failure has been reported. 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
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 →

Related recalls

Same manufacturer · Advanced Nutriceuticals, LLC

See all →

Same hazard · sterility failure

See all →