Seroyal International, a division of Atrium Innovations recalls Genestra brand AFA-gen capsule 15 mg Niacin/ capsule 300 mg Blue Green Algae / capsule 2 capsules, twice daily Dietary…

Recall date

July 27, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

F-1756-2018

FDA classification

Class II

Brand / firm

Seroyal International, a division of Atrium Innovations

Sold / distributed

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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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