Recall events
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Event 77605
Event summary
Timeline bucket May 24, 2017
Product types Drug
Classifications Class III
Statuses Terminated
Recalling firm wording Shionogi Inc.
Dossier provenance
Source snapshots represented here
openFDA Drug Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
How coverage and grouping work
Device root-cause evidence is not applicable to this event.
No grouped product has the official product type device; this is not an unavailable-enrichment finding.
Complete imported group
Every recalled product in this event
2 official enforcement rows
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
drug · product 1 of 2
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
D-0981-2017
Recall number D-0981-2017
Initiated May 24, 2017
Classification Class III
Status Terminated
Quantity 6304 bottles
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
Failed Dissolution Specifications
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Failed Dissolution Specifications: Low dissolution results were obtained during stability testing
Code information Lot #: 5H66200103G, Exp. June 2018.
Distribution pattern Nationwide
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[9689]
FDA event record
· Exact recall-number query on openFDA
drug · product 2 of 2
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
D-0982-2017
Recall number D-0982-2017
Initiated May 24, 2017
Classification Class III
Status Terminated
Quantity 455 bottles
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
Failed Dissolution Specifications
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Failed Dissolution Specifications: Low dissolution results were obtained during stability testing
Code information Lot #: 5H66200103, Exp. June 2018
Distribution pattern Nationwide
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[9081]
FDA event record
· Exact recall-number query on openFDA
