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

FDA recall notice · announced August 15, 2018 · Seroyal International, A Division Of Atrium Innovations

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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

Reason for recall

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

Notes

Distribution: Product was distributed throughout the United States and Canada (see attached document for list of Canadian consignees).
Lot/code information: Lot # 6E436-0; Product Code # 07596; Expiry Date: 09/2018
Quantity: 4,226 bottles (1691 Canada and 2535 USA)
Status: Terminated
Products in this recall event:
- 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, pac (F-1756-2018)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.