Medichem S.A.

FDA Regulatory Profile

Medichem S.A. appears in FDA public data with 2 recalls — including 1 Class I (most serious) —, 0 510(k) clearances, 5 FDA inspections, and 0 compliance actions on record. Its most recent recall (D-0055-2021, Class II) was initiated on October 2, 2020.

Summary

Total Recalls
2 (1 Class I)
510(k) Clearances
0
Inspections
5
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-0055-2021Class IIChlorhexidine Gluconate 20% 0012 Medichem, S.A. NDC 53296-0012-0October 2, 2020
D-1534-2020Class IChlorhexidine Gluconate 0012 For Manufacturing, Processing or Repacking, RX Only, Medichem, S.A. PolJune 24, 2020