Shionogi Inc.

FDA Regulatory Profile

Summary

Total Recalls
5
510(k) Clearances
0
Inspections
14
Compliance Actions
1

Recent Recalls

NumberClassProductDate
D-0219-2018Class IIIMefenamic Acid Capsules, USP, 250 mg, 30-count bottle, Rx only, Distributed by Prasco Laboratories, May 24, 2017
D-0982-2017Class IIIPONSTEL (Mefanamic Acid) USP, 250 mg capsules, 30-count bottles, Rx Only, Manufactured for: ShionogiMay 24, 2017
D-0981-2017Class IIIMefenamic Acid, 250mg capsules, packaged in 30-count bottles, Rx Only, Distributed by: Prasco LaboraMay 24, 2017
D-1284-2015Class IIINisoldipine Extended Release Tablets, 17 mg, packaged as a) Sular (nisoldipine) Extended Release taJuly 24, 2015
D-1398-2012Class IINisoldipine Extended Release Tablets, 17mg, 100 count bottle, Rx only, Manufactured for: Prasco LabMarch 8, 2012