Genestra AFA-gen Capsules Recalled for Excess Microcystins
Seroyal International is recalling Genestra AFA-gen capsules because microcystin levels exceeded the specified limit of 1 ppm.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a contaminant exceeding specification limits without reported illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Seroyal International, a division of Atrium Innovations, is recalling Genestra brand AFA-gen capsules. The product is a dietary supplement containing 15 mg Niacin and 300 mg Blue Green Algae per capsule, packaged in 90-count bottles. The recall involves 4,226 bottles distributed throughout the United States and Canada.
The recall was initiated because microcystin levels in the product were found to be above the specification limit of not more than 1 ppm, as defined in the Raw Material Specification. The affected product is identified by Lot # 6E436-0, Product Code # 07596, and an expiry date of 09/2018.
Consumers who have purchased this product should stop using it and contact the recalling firm for further instructions.
The recalled product
- Product
- Genestra brand AFA-gen capsule 15 mg Niacin/ capsule 300 mg Blue Green Algae / capsule 2 capsules, twice daily Dietary supplement 90 capsules, White 150cc HDPE Bottle with Desiccant and white cap, packed as 12 bottles / shipper case
- 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 (3)
- Lot # 6E436-0
- Product Code # 07596
- Expiry Date: 09/2018
Distribution
Distribution scope not specified by the agency.
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