PlainRecalls
FDA Food Moderate Class II Terminated

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

Reported: August 15, 2018 Initiated: July 27, 2018 #F-1756-2018

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

Reason for Recall

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

Details

Units Affected
4,226 bottles (1691 Canada and 2535 USA)
Distribution
Product was distributed throughout the United States and Canada (see attached document for list of Canadian consignees).
Location
Richmond Hill, Ontario

Frequently Asked Questions

What product 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. Recalled by Seroyal International, a division of Atrium Innovations. Units affected: 4,226 bottles (1691 Canada and 2535 USA).
Why was this product recalled?
Microcystins level found to be above the specification limit of NMT1 ppm as per Raw Material Specification.
Which agency issued this recall?
This recall was issued by the FDA Food on August 15, 2018. Severity: Moderate. Recall number: F-1756-2018.