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Shionogi Inc.

No ongoing recalls currently shown

Based on the official records currently available to Public Health Trace, no recalls naming Shionogi Inc. are currently shown as ongoing. The 5 records below are historical recall records.

Public Health Trace has 5 recalls naming Shionogi Inc. as the recalling firm, republished from official FDA and USDA sources.

Recall history - 5 terminated records

Recalls by year

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

Recalls by year
YearRecalls
20121
20151
20172
20181
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FDA Recall TerminatedTerminated: February 28, 2018Historical 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

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FDA Recall TerminatedTerminated: February 28, 2018Historical 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

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FDA Recall TerminatedTerminated: February 28, 2018Historical 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

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FDA Recall TerminatedTerminated: April 14, 2016Historical 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

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FDA Recall TerminatedTerminated: February 7, 2013Historical 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

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Showing 1–5 of 5 results

Some FDA recall records on this page come from FDA's Enforcement Report database. Not every Enforcement Report record has a separate FDA.gov recall-announcement page.

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.

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