Darmerica, LLC

FDA Regulatory Profile

Darmerica, LLC appears in FDA public data with 1 recall — including 1 Class I (most serious) —, 0 510(k) clearances, 3 FDA inspections, and 1 compliance action on record. Its most recent recall (D-0125-2020, Class I) was initiated on September 6, 2019.

Summary

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

Recent Recalls

NumberClassProductDate
D-0125-2020Class IQuinacrine Dihydrochloride (98.25%), bulk API product, packaged in a) 500 g NDC# 71052-530-05; b) 50September 6, 2019