High Dose B12 Injection Recalled for Sterility Assurance Concerns
Advanced Nutriceuticals is recalling High Dose B12 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 recall is classified as FDA Class II and involves a lack of assurance of sterility, which poses a risk of serious injury or death from infection, meeting the criteria for a Severe rating.
Plain-English summary
Advanced Nutriceuticals, LLC is recalling High Dose B12, 10 MG/ML, 10 ML vials. 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 #1029202007 and has an expiration date of 12/29/20. The product was distributed in California, Colorado, Florida, Indiana, Kentucky, Ohio, and Texas. The recall is classified as Class II by the FDA.
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- HIGH DOSE B12, 10 MG/ML, 10 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
- Manufacturer
- Advanced Nutriceuticals, LLC
- Category
- Drug — Injectable Medication
- 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 #1029202007
- Exp 12/29/20
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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