FDA recall F-1756-2018

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 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

Product was distributed throughout the United States and Canada (see attached document for list of Canadian consignees).

Key facts

Status

Terminated

Initiation date

2018-07-27

Report date

2018-08-15

Termination date

2020-11-25

Voluntary/Mandated

Voluntary: Firm initiated

Location

Richmond Hill, Ontario, Canada

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=F-1756-2018