F-1756-2018 Class II Terminated
FDA food recall F-1756-2018 was initiated by Seroyal International, a division of Atrium Innovations on July 27, 2018 and is designated Class II. Reason for recall: Microcystins level found to be above the specification limit of NMT1 ppm as per Raw Material Specification. The recall status is terminated (terminated November 25, 2020). Affected quantity: 4,226 bottles (1691 Canada and 2535 USA).
Recall Details
- Product Type
- Food
- Report Date
- August 15, 2018
- Initiation Date
- July 27, 2018
- Termination Date
- November 25, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4,226 bottles (1691 Canada and 2535 USA)
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.
Distribution Pattern
Product was distributed throughout the United States and Canada (see attached document for list of Canadian consignees).
Code Information
Lot # 6E436-0; Product Code # 07596; Expiry Date: 09/2018