The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0140-2021·Announced 2020-12-23

FDA Recalls Thymosin Beta-4 Vials Due to Sterility Concerns

Advanced Nutriceuticals, LLC is recalling Thymosin Beta-4 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 rating under the rubric, particularly given the risk of infection from non-sterile medical products.

Plain-English summary

The U.S. Food and Drug Administration (FDA) is recalling specific vials of THYMOSIN BETA - 4, 2000 MCG/ML, 5 ML, 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 distributed in California, Colorado, Florida, Indiana, Kentucky, Ohio, and Texas. The recall covers three vials from specific lots: Lot #1110202005 (Exp 12/10/2020), Lot #1102202015 (Exp 12/08/2020), and Lot #1105202009 (Exp 12/20/2020). The product was associated with The Guyer Institute of Molecular Medicine in Indianapolis, IN.

Consumers should check their inventory for these specific lot numbers and expiration dates. If the product is found, it should be returned to the point of purchase or disposed of according to local regulations. No specific instructions for disposal are provided in the source text.

The recalled product

Product
THYMOSIN BETA - 4, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Manufacturer
Advanced Nutriceuticals, LLC
Category
Drug — Biologic / Sterile Product
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 #1110202005
  • Exp 12/10/2020
  • Lot #1102202015
  • Exp 12/08/2020
  • Lot #1105202009
  • Exp 12/20/2020

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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