Why it was recalled
Microcystins level found to be above the specification limit of NMT1 ppm as per Raw Material Specification.
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
Lot numbers, UPCs & expiration codes
Lot # 6E436-0; Product Code # 07596; Expiry Date: 09/2018
Where it was sold
Product was distributed throughout the United States and Canada (see attached document for list of Canadian consignees).
What to do if you have this product
- Compare the brand, size, and lot/UPC codes on your package with the codes above.
- If it matches, don't eat it. Return it to the store for a refund or throw it away.
- Wash surfaces and containers that touched the product.
- If you feel sick after eating it, contact your doctor. In an emergency call 911.
Recall details
- Recall number
- F-1756-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 27, 2018
- FDA report date
- Aug 15, 2018
- Quantity
- 4,226 bottles (1691 Canada and 2535 USA)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Seroyal International, a division of Atrium Innovations
Original FDA data
Every field from FDA enforcement report F-1756-2018, exactly as published.
Show all FDA fields
- City
- Richmond Hill
- State
- Ontario
- Status
- Terminated
- Country
- Canada
- Event ID
- 80661
- Address
- 490 Elgin Mills Rd E
- Code information
- Lot # 6E436-0; Product Code # 07596; Expiry Date: 09/2018
- Report date
- Aug 15, 2018
- Product type
- Food
- Recall number
- F-1756-2018
- Classification
- Class II
- Recalling firm
- Seroyal International, a division of Atrium Innovations
- Product quantity
- 4,226 bottles (1691 Canada and 2535 USA)
- Termination date
- Nov 25, 2020
- Reason for recall
- Microcystins level found to be above the specification limit of NMT1 ppm as per Raw Material Specification.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Product was distributed throughout the United States and Canada (see attached document for list of Canadian consignees).
- Recall initiation date
- Jul 27, 2018
- Initial firm notification
- Letter
- Center classification date
- Aug 6, 2018