Advanced Nutriceuticals Recalls LL-37 Vials Due to Sterility Concerns
Advanced Nutriceuticals is recalling LL-37 vials because production processes cannot assure sterility. The product was distributed to 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 medical product, which poses a significant risk of infection or serious injury.
Plain-English summary
Advanced Nutriceuticals, LLC is recalling LL-37, 2000 MCG/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 #1105202006 with an expiration date of 12/18/2020. Distribution was limited to California, Colorado, Florida, Indiana, Kentucky, Ohio, and Texas.
Consumers and healthcare providers should stop using the recalled product and contact Advanced Nutriceuticals, LLC for further instructions.
The recalled product
- Product
- LL-37, 2000 MCG/ML, 2 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
- Manufacturer
- Advanced Nutriceuticals, LLC
- 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 #1105202006
- Exp 12/18/2020
Distribution
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.
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