The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0128-2021·Announced 2020-12-23

FDA Recalls CJC-1295 Vials Due to Sterility Concerns

Advanced Nutriceuticals, LLC is recalling CJC-1295 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 associated with non-sterile medical products.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a recall for CJC-1295, 2000 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 was distributed in California, Colorado, Florida, Indiana, Kentucky, Ohio, and Texas. The recall includes six vials associated with specific lot numbers and expiration dates listed in the agency's records.

Consumers who have this product should stop using it and contact the recalling firm or their healthcare provider for further instructions.

The recalled product

Product
CJC-1295, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Manufacturer
Advanced Nutriceuticals, LLC
Category
Drug — Injectable
Hazard
Affected units
6

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 (11)

  • Lot #1029202004
  • Exp 11/29/2020
  • Lot #1102202001
  • 102202009
  • Exp 12/08/2020
  • Lot #1105202009
  • Exp 12/20/2020
  • Lot #1110202003
  • Exp 12/10/2020
  • 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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