The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0131-2021·Announced 2020-12-23

FDA Recalls AOD-9604 Vials Due to Sterility Concerns

Advanced Nutriceuticals, LLC is recalling AOD-9604 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 health risk potential.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a recall for AOD-9604, 1200 MCG/ML, 5 ML vials manufactured by Advanced Nutriceuticals, LLC. The recall is due to concerns with production processes that cannot assure the sterility of products intended to be sterile.

The affected product is associated with The Guyer Institute of Molecular Medicine in Indianapolis, IN. The recall covers three vials per unit. Specific lots involved include Lot #1029202003 (Exp 11/29/2020), Lot #1110202002 (Exp 12/10/2020), and Lot #1112202001 (Exp 12/12/2020).

The product was distributed in California, Colorado, Florida, Indiana, Kentucky, Ohio, and Texas. Consumers should stop using the product and contact the recalling firm for further instructions.

The recalled product

Product
AOD-9604, 1200 MCG/ML, 5 ML vial The Guyer Institute of Molecular Medicine, Indianapolis, IN
Manufacturer
Advanced Nutriceuticals, LLC
Category
Drug — Injectable
Hazard
Affected units
3

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 (6)

  • Lot #1029202003
  • Exp 11/29/2020
  • Lot #1110202002
  • Exp 12/10/2020
  • Lot #1112202001
  • Exp 12/12/2020

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 →

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