Skip to main content

Shionogi Inc.

Recalls

Recalls by year

A bar chart of the number of recalls naming this company by year.

Recalls by year
YearRecalls
20121
20151
20172
20181
Download CSV

FDA Recall Terminated Historical recordClass III

Mefenamic Acid Capsules, USP, 250 mg, 30-count bottle, Rx only, Distributed by Prasco Laboratories, Mason, OH 45040, Manufactured by Halo Pharmaceutical Inc., Whippany, NJ 07981, NDC 66993-070-30

by Shionogi Inc.

Reason
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
Published
January 24, 2018
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass III

PONSTEL (Mefanamic Acid) USP, 250 mg capsules, 30-count bottles, Rx Only, Manufactured for: Shionogi Inc. Florham Park, NJ 07932 Manufactured by: Halo Pharmaceutical Inc. Whippany, NJ 07981

by Shionogi Inc.

Reason
Failed Dissolution Specifications: Low dissolution results were obtained during stability testing
Published
July 26, 2017
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass III

Mefenamic Acid, 250mg capsules, packaged in 30-count bottles, Rx Only, Distributed by: Prasco Laboratories Mason, OH 45040 USA, Manufactured by: Halo Pharmaceutical Inc. Whippany, NJ 07981, NDC 66993-070-30

by Shionogi Inc.

Reason
Failed Dissolution Specifications: Low dissolution results were obtained during stability testing
Published
July 26, 2017
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass III

Nisoldipine Extended Release Tablets, 17 mg, packaged as a) Sular (nisoldipine) Extended Release tablets, 100-count bottle (NDC 59630-501-10, UPC 3 59630 50110 5), Manufactured for: Shionogi, Inc., Florham Park, NJ 07932; and b) Nisoldipine Extended Release tablets, 100-count bottle (NDC 66993-473-02, UPC 3 6693 47302 4), Manufactured for: Prasco Laboratories, Mason, OH 45040; Rx only; Manufactured by: Aenova France SAS, 38291 Saint Quentin-Falavier, France.

by Shionogi Inc.

Reason
Failed Dissolution Specifications
Published
August 12, 2015
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Nisoldipine Extended Release Tablets, 17mg, 100 count bottle, Rx only, Manufactured for: Prasco Laboratories Mason OH 45040, Manufactured by SkyePharma production SAS 38297, Saint Quentin-Pallavier, France, NDC: 0677-1979-01

by Shionogi Inc.

Reason
Failed USP Dissolution Test Requirements: Out of Specification dissolution result at 18 month time point
Published
July 4, 2012
Distribution
PA

View recall →

Showing 1–5 of 5 results

This page lists recalls that name Shionogi Inc. as the recalling firm in the official source notice. It is not a safety rating, ranking, or statement that the company acted negligently. Read the full medical disclaimer.