ProThera, Inc. dba SFI USA

FDA Regulatory Profile

ProThera, Inc. dba SFI USA appears in FDA public data with 2 recalls, 0 510(k) clearances, 3 FDA inspections, and 0 compliance actions on record. Its most recent recall (F-1101-2019, Class III) was initiated on January 17, 2019.

Summary

Total Recalls
2
510(k) Clearances
0
Inspections
3
Compliance Actions
0

Recent Recalls

NumberClassProductDate
F-1101-2019Class IIIKlaire Labs Melatonin Lozenge Formula Fast Dissolving 1 mg tablets; Packed in a 75 cc HDPE Bottle January 17, 2019
F-1186-2019Class IIKlaire Labs Reduced L-Glutathione 150 mg capsules, single capsule dose 100 vegetarian capsules SDecember 13, 2018