FDA recall F-1112-2014

Global Health Laboratories, LLC · Class II · food

Product

(a) ONEBODE Flo daily, probiotic enzyme digestive, 90 capsules, dietary supplement, Product No. T00135, UPC 0 14834 00135 5; (b) ONEBODE Flo for Family, probiotic enzyme digestive, 360 capsules, dietary supplement, Product No. T00109, UPC 0 14834 00109 6; (c) ONEBODE Flo daily, probiotic enzyme digestive, 6 capsules, dietary supplement (SAMPLE PACK), Product No. T00111, UPC 0 14834 00111 9 --- Mfg. for OneBode, Chandler, Arizona 85226

Reason for recall

The finished dietary supplement product was manufactured with ingredients found to be contaminated with chloramphenicol, an antibiotic, above levels of 0.3 ppb.

Distribution

Arizona

Key facts

Status
Terminated
Initiation date
2013-11-07
Report date
2013-12-25
Termination date
2017-03-10
Voluntary/Mandated
Voluntary: Firm initiated
Location
Amityville, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=F-1112-2014