Deva Holding AS - Cerkezkoy Subesi

FDA Regulatory Profile

Summary

Total Recalls
6
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-1511-2019Class IITemozolomide Capsules, 140 mg, packaged in a) 5-count bottle (NDC 67877-540-07), b) 14-count bottle July 16, 2019
D-1509-2019Class IITemozolomide Capsules, 20 mg, packaged in a) 5-count bottle (NDC 67877-538-07), b) 14-count bottle (July 16, 2019
D-1512-2019Class IITemozolomide Capsules, 180 mg, packaged in a) 5-count bottle (NDC 67877-541-07), b) 14-count bottle July 16, 2019
D-1510-2019Class IITemozolomide Capsules, 100 mg, packaged in a) 5-count bottle (NDC 67877-539-07), b) 14-count bottle July 16, 2019
D-1513-2019Class IITemozolomide Capsules, 250 mg, 5-count bottle, Rx only, Manufactured by: Deva Holding A.S., 1 MerkezJuly 16, 2019
D-1508-2019Class IITemozolomide Capsules, 5 mg, packaged in a) 5-count bottle (NDC 67877-537-07), b) 14-count bottle (NJuly 16, 2019