FDAClass IIAugust 15, 2018

Genestra brand AFA-gen capsule 15 mg Niacin/ capsule recall

Genestra brand AFA-gen capsule 15 mg Niacin/ capsule 300 mg Blue Green Algae / capsule 2 capsules, twice daily Dietary supplement 90 capsules, White…

Why was Genestra brand AFA-gen capsule 15 mg Niacin/ capsule recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

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…
Recalling firm
Seroyal International, a division of Atrium Innovations
Quantity
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).
Recall date
August 15, 2018
Classification
Class II
Status
Terminated
Agency
FDA (food)
Open FDA enforcement record Latest FDA food recalls