The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0132-2021·Announced 2020-12-23

FDA Recalls BPC-157 Vials Due to Sterility Concerns

Advanced Nutriceuticals, LLC is recalling BPC-157 vials because production processes cannot assure the sterility of the product.

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 associated with non-sterile medical products.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a recall for BPC-157, 2000 MCG/ML, 5 ML vials manufactured by Advanced Nutriceuticals, LLC. The product is associated with The Guyer Institute of Molecular Medicine in Indianapolis, IN. The recall involves four vials with specific lot numbers and expiration dates ranging from December 2020.

The recall is being conducted due to a lack of assurance of sterility. The FDA cites concerns with production processes that cannot guarantee the sterility of products intended to be sterile. This classification is designated as Class II by the agency.

The affected product was distributed in California, Colorado, Florida, Indiana, Kentucky, Ohio, and Texas. Consumers who possess these specific vials should stop using them and contact the recalling firm or their healthcare provider for instructions on how to return or dispose of the product.

The recalled product

Product
BPC-157, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Manufacturer
Advanced Nutriceuticals, LLC
Category
Drug — Biological / Peptide
Hazard
Affected units
4

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 (8)

  • Lot #1102202009
  • Exp 12/08/2020
  • Lot #1105202009
  • Exp 12/20/2020
  • Lot #1110202001
  • Exp 12/15/2020
  • Lot #1112202004
  • 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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