Biocon Inc

FDA Regulatory Profile

Summary

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

Recent Recalls

NumberClassProductDate
D-0817-2016Class IIISimvastatin Tablets, USP 5 mg Rx only, a) 90 count (NDC 24658-0300-90) and b) 1000 count (NDC 24658-March 24, 2016

Recent 510(k) Clearances

K-NumberDeviceDate
K833360HEP-2 CELLSNovember 3, 1983
K833358MRC-5 CELLSNovember 3, 1983
K833359WI-38 CELLSNovember 3, 1983