BioDose Pharma Recalls GlutaDose Antioxidant Supplement Due to Bacillus cepacia Contamination Risk
BioDose Pharma is recalling GlutaDose 400 mg Antioxidant & Immune Detox oral solution because the product has the potential to be contaminated with Bacillus cepacia.
The agency’s classification
FDA (Food): 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a high-risk pathogen (Bacillus cepacia) without reported illness, which aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
BioDose Pharma, LLC is recalling 2,231 cases of GlutaDose 400 mg Antioxidant & Immune Detox 30 day supply Dietary Supplement Oral Solution Citric Flavor. The recall involves 30 units of 10ml vials per carton, specifically Lot 90013 with an expiration date of 03/2021.
The recall was initiated because the product has the potential to be contaminated with Bacillus cepacia. The agency has classified this recall as Class II. The product was distributed to US consignees only.
Consumers who have this product should stop using it and contact BioDose Pharma, LLC for further instructions or a refund. The source text does not report any specific illnesses or injuries associated with this recall.
The recalled product
- Product
- GlutaDose 400 mg Antioxidant & Immune Detox 30 day supply Dietary Supplement Oral Solution Citric Flavor
- Manufacturer
- BioDose Pharma, LLC
- Category
- Food — Dietary Supplement
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 (1)
- 30 units of 10ml vials per carton Lot 90013 EXP 03/2021
Distribution
Distribution scope not specified by the agency.
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