BoKU International

FDA Regulatory Profile

BoKU International appears in FDA public data with 3 recalls — including 3 Class I (most serious) —, 0 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent recall (F-2516-2014, Class I) was initiated on July 30, 2014.

Summary

Total Recalls
3 (3 Class I)
510(k) Clearances
0
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
F-2516-2014Class IBoku Super Food 2.0, Product Sizes: 28.2 ozJuly 30, 2014
F-2517-2014Class IBoku Super Food 3.0, Product Sizes: 10 oz.July 30, 2014
F-2515-2014Class IBoku Super Protein 3.0, Product Sizes: 21.2 oz, 1 oz., bulk.July 30, 2014