RECORDATI RARE DISEASES INC.

FDA Regulatory Profile

RECORDATI RARE DISEASES INC. appears in FDA public data with 1 recall, 0 510(k) clearances, 3 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2012-2025, Class II) was initiated on June 11, 2025.

Summary

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

Recent Recalls

NumberClassProductDate
Z-2012-2025Class IICaphosol Artificial Saliva (32 doses sachet box). 64 x 15 mL sachets aqueous solution (32 sachets SJune 11, 2025