Broncolin, S.A. de C.V.

FDA Regulatory Profile

Broncolin, S.A. de C.V. appears in FDA public data with 2 recalls — including 1 Class I (most serious) —, 0 510(k) clearances, 3 FDA inspections, and 1 compliance action on record. Its most recent recall (D-1578-2020, Class I) was initiated on July 27, 2020.

Summary

Total Recalls
2 (1 Class I)
510(k) Clearances
0
Inspections
3
Compliance Actions
1

Recent Recalls

NumberClassProductDate
D-1578-2020Class IHERBACIL, Antiseptic Hand Sanitizer, 70% Alcohol, (Alcohol) 70%, packaged as a) 4.22 fl. oz. (125ml)July 27, 2020
D-1577-2020Class IIHERBACIL, Antiseptic Hand Sanitizer, 70% Alcohol, (Alcohol) 70%, packaged as a) 4.22 fl. oz. (125ml)July 27, 2020