Shionogi Recalls
5 recalls on record · July 4, 2012 to January 24, 2018 · Drugs
Recalls by year
12
15
17
18
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
January 24, 2018DrugsFDA
Shionogi Inc. recalls Mefenamic Acid Capsules, USP, 250 mg, 30-count bottle, Rx only, Distributed by Prasco Laboratories, Mason, OH 45040, Man
Hazard: Presence of foreign substance: The recall was initiated due to black particles being observed while performing routine post-release stability testing on Mefenamic acid capsules
July 26, 2017DrugsFDA
Shionogi Inc. recalls PONSTEL (Mefanamic Acid) USP, 250 mg capsules, 30-count bottles, Rx Only, Manufactured for: Shionogi Inc. Florham Park,
Hazard: Failed Dissolution Specifications: Low dissolution results were obtained during stability testing
July 26, 2017DrugsFDA
Shionogi Inc. recalls Mefenamic Acid, 250mg capsules, packaged in 30-count bottles, Rx Only, Distributed by: Prasco Laboratories Mason, OH 450
Hazard: Failed Dissolution Specifications: Low dissolution results were obtained during stability testing
August 12, 2015DrugsFDA
Shionogi Inc. recalls Nisoldipine Extended Release Tablets, 17 mg, packaged as a) Sular (nisoldipine) Extended Release tablets, 100-count bot
Hazard: Failed Dissolution Specifications
July 4, 2012DrugsFDA
Shionogi Inc. recalls Nisoldipine Extended Release Tablets, 17mg, 100 count bottle, Rx only, Manufactured for: Prasco Laboratories Mason OH 4
Hazard: Failed USP Dissolution Test Requirements: Out of Specification dissolution result at 18 month time point