FDA recall F-0061-2020

Threshold Enterprises Ltd · Class III · food

Product

Source Naturals Dietary Supplement Brain Charge Advanced Cognitive Support 30 tablets, 60 tablets Manufactured for: Source Natural, Inc. PO Box 2118 Santa Cruz, CA 95062 Item Code: SN2613, SN2614 Item UPC: 021078026136, 021078026143

Reason for recall

Labeling error; incorrect supplement facts panel and label claims for two ingredients were lower than the product formulation.

Distribution

U.S. distribution to the following: AL, AZ, CA, CO, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MO, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, TN, TX, UT, WA No foreign distribution.

Key facts

Status
Terminated
Initiation date
2019-09-10
Report date
2019-10-30
Termination date
2020-02-03
Voluntary/Mandated
Voluntary: Firm initiated
Location
Scotts Valley, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=F-0061-2020