The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0130-2021·Announced 2020-12-23

PT-141 Injection Recalled Due to Sterility Assurance Concerns

Advanced Nutriceuticals is recalling PT-141 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 classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls involving significant injury/property-damage reports or structural defects are rated Severe (4). While no specific injuries are reported in the text, the lack of sterility assurance in an injectable product represents a significant risk of harm, fitting the Severe criteria for Class II recalls with potential for serious health consequences.

Plain-English summary

Advanced Nutriceuticals, LLC is recalling PT-141, 10 MG/ML, 2 ML vials manufactured for 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 is identified by Lot #1112202006 with an expiration date of 12/12/2020. The recall covers one vial per unit. Distribution was limited to California, Colorado, Florida, Indiana, Kentucky, Ohio, and Texas.

Consumers who have this product should stop using it and contact the recalling firm for instructions on return or disposal. The FDA has classified this as a Class II recall.

The recalled product

Product
PT-141, 10 MG/ML, 2 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Manufacturer
Advanced Nutriceuticals, LLC
Category
Drug — Injectable Medication
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 #1112202006
  • 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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