Exact-Rx Inc

FDA Regulatory Profile

Exact-Rx Inc appears in FDA public data with 1 recall, 0 510(k) clearances, 2 FDA inspections, and 1 compliance action on record. Its most recent recall (D-1465-2016, Class III) was initiated on June 2, 2016.

Summary

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

Recent Recalls

NumberClassProductDate
D-1465-2016Class IIIUrea (50% Urea in a Cream Base), a) Net Wt. 5 oz (142 g), (NDC 42808-0200-05) b) Net Wt. 9 oz (225 gJune 2, 2016