FDA recalls · F-1756-2018
Seroyal International, a division of Atrium Innovations recall
- FoodGenestra 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
- ReasonMicrocystins level found to be above the specification limit of NMT1 ppm as per Raw Material Specification.
- ClassClass II: the food could cause temporary or treatable health problems
- StatusClosed by FDA, ended 2020-11-25
- DatesFirm started it 2018-07-27. In FDA's enforcement report 2018-08-15.
- Sold inProduct was distributed throughout the United States and Canada (see attached document for list of Canadian consignees).
- Amount4,226 bottles (1691 Canada and 2535 USA)
- CodesLot # 6E436-0; Product Code # 07596; Expiry Date: 09/2018
- FirmSeroyal International, a division of Atrium Innovations, Richmond Hill, Ontario · Voluntary: Firm initiated
Products we list
None. We tie a recall to a product only by a barcode printed in the recall, and this one names none we list. That does not mean the recalled food is missing from our listings.
From FDA's enforcement report, via openFDA (CC0): raw data for this recall. FDA's own Enforcement Report search finds it by its number, F-1756-2018. Class meanings: FDA.