Advanced Nutriceuticals Recalls FGL Vials Due to Sterility Concerns
Advanced Nutriceuticals is recalling FGL 10 mg/ml vials because production processes cannot assure sterility. The product was distributed in seven states.
What this means for you
Illness, injury, or structural failure has been reported. 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 risks such as sterility failures in medical products are categorized as Severe.
Plain-English summary
Advanced Nutriceuticals, LLC is recalling FGL, 10 MG/ML, 3 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 1 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 or their healthcare provider for instructions on return or disposal.
The recalled product
- Product
- FGL, 10 MG/ML, 3 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 #1112202006
- Exp 12/12/2020
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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