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Recall Observatory FDA recall evidence

Food 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

F-1756-2018

July 27, 2018

Class II

Product summary

Firm
Seroyal International, a division of Atrium Innovations
Event
Event 80661
Status
Terminated
Classification
Class II
Quantity
4,226 bottles (1691 Canada and 2535 USA)
Official record key
food-enforcement:F-1756-2018

Official wording

Reason: Microcystins level found to be above the specification limit of NMT1 ppm as per Raw Material Specification.

Code information: Lot # 6E436-0; Product Code # 07596; Expiry Date: 09/2018

Distribution pattern: Product was distributed throughout the United States and Canada (see attached document for list of Canadian consignees).

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Microcystins level found to be above the specification limit of NMT1 ppm as per Raw Material Specification.