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Genestra brand AFA-gen capsule 15 mg Niacin/ capsule 300 mg…: FDA Recall F-1756-2018

Agency action: Jul 27, 2018Record ID: F-1756-2018

What happened

Original notice title

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…

From the archived source record

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

What the official notice says to do

Check the original notice for the instructions that apply to the named product, company, and affected lots.

Read the official notice →

Status and source details

Status recorded in the archive: Terminated
FDA recall classification: Class II
Recall initiated by: Voluntary: Firm initiated
Report date: Aug 15, 2018
Termination date in the archive: Nov 25, 2020
Source checked: Jul 16, 2026
Record revision: 3e168ac43fee

This is a dated record. Its current status may have changed since the source was captured. A record applies to its stated scope; it is not a safety rating for every product from a company.

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Source presentation by Dr. Edward M.Kim, PharmD · Clinical Director, SupplementSafety editorial team · How we prepare records

What is affected

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
Company: Seroyal International, a division of Atrium Innovations
Lot / identifier: Lot # 6E436-0; Product Code # 07596; Expiry Date: 09/2018
Market / distribution: Product was distributed throughout the United States and Canada (see attached document for list of Canadian consignees).