Class IITerminated in FDA datasetRecall initiated Jul 27, 2018

Genestra brand AFA-gen capsule 15 mg Niacin/ capsule 300 mg Blue Green Algae / capsule 2…

Recalling firm: Seroyal International, a division of Atrium Innovations

Why it was recalled

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

Historical recall record. This is not a new recall announcement. “Terminated” describes the FDA recall process; it does not certify that an individual package is safe. FDA termination date: Nov 25, 2020.

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ProductGenestra 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

FDA code information

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

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Full FDA record and distribution details

Original product description

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

Extracted codes and context

TypeCode / valueContext
lot6E436-0Lot # 6E436-0; Product Code # 07596; Expiry Date: 09/2018

Original FDA recall reason

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

Recall details

Recall number
F-1756-2018
Event ID
80661
FDA status
Terminated
Initiated
Jul 27, 2018
Reported
Aug 15, 2018
Classified
Aug 6, 2018
Terminated
Nov 25, 2020
Quantity
4,226 bottles (1691 Canada and 2535 USA)
Location
Richmond Hill, Ontario, Canada
Initiation type
Voluntary: Firm initiated
Notification
Letter

Where it was distributed

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

FDA source record · F-1756-2018

Data updated September 16, 2026. View official FDA data ↗

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