Kalchem International, Inc.

FDA Regulatory Profile

Kalchem International, Inc. appears in FDA public data with 1 recall, 0 510(k) clearances, 5 FDA inspections, and 1 compliance action on record. Its most recent recall (D-0582-2018, Class II) was initiated on February 19, 2018.

Summary

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

Recent Recalls

NumberClassProductDate
D-0582-2018Class IIVardenafil HCl, USP (trihydrate), 500 GM Part # 330-05, Rx only, For Manufacturing, Repackaging and February 19, 2018