The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0144-2021·Announced 2020-12-23

Advanced Nutriceuticals Recalls Pentosan Polysulfate Vials Due to Sterility Concerns

Advanced Nutriceuticals, LLC is recalling Pentosan Polysulfate 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 agency classification is FDA Class II, and the hazard involves a lack of assurance of sterility for a product intended to be sterile, which poses a significant risk of serious injury or infection.

Plain-English summary

Advanced Nutriceuticals, LLC is recalling Pentosan Polysulfate, 300 MG/ML, 5 ML vials manufactured by The Guyer Institute of Molecular Medicine in Indianapolis, IN. The recall is being conducted because concerns regarding production processes mean the company cannot assure the sterility of the products, which are intended to be sterile.

The affected product is identified by Lot #1110202006 with an expiration date of 12/10/2020. The vials were distributed in California, Colorado, Florida, Indiana, Kentucky, Ohio, and Texas.

Consumers who have this product should stop using it and contact Advanced Nutriceuticals, LLC for further instructions or a refund.

The recalled product

Product
Pentosan Polysulfate, 300 MG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Manufacturer
Advanced Nutriceuticals, LLC
Category
Drug — Injectable
Hazard
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 #1110202006
  • exp 12/10/2020

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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