Shionogi recalls
FDA enforcement reports naming Shionogi Inc. as the recalling firm.
- Recall reports
- 5
- Class I (serious)
- 0
- Most recent report
- Jan 24, 2018
- Jan 24, 2018Mefenamic Acid Capsules, USP, 250 mg, 30-count bottle, Rx only, Distributed by Prasco L…Drug · Shionogi Inc.Presence of foreign substance: The recall was initiated due to black particles being observed while performing routine post-release stability testing on Mefenamic acid capsulesClass III
- Jul 26, 2017Mefenamic Acid, 250mg capsules, packaged in 30-count bottles, Rx Only, Distributed by:…Drug · Shionogi Inc.Failed Dissolution Specifications: Low dissolution results were obtained during stability testingClass III
- Jul 26, 2017PONSTEL (Mefanamic Acid) USP, 250 mg capsules, 30-count bottles, Rx Only, Manufactured…Drug · Shionogi Inc.Failed Dissolution Specifications: Low dissolution results were obtained during stability testingClass III
- Aug 12, 2015Nisoldipine Extended Release Tablets, 17 mg, packaged as a) Sular (nisoldipine) Extend…Drug · Shionogi Inc.Failed Dissolution SpecificationsClass III
- Jul 4, 2012Nisoldipine Extended Release Tablets, 17mg, 100 count bottle, Rx only, Manufactured fo…Drug · Shionogi Inc.Failed USP Dissolution Test Requirements: Out of Specification dissolution result at 18 month time pointClass II