Exact FDA event identifier

Event 88224

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket: July 02, 2021
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: The Harvard Drug Group

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

1 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 1

NIFEdipine EXTENDED-RELEASE TABLETS, USP 30 mg Rx only packaged as a) 100 count unit dose carton, NDC 0904-7080-61; b) 50 count unit dose carton, NDC 0904-7080-06: Distributed by: Ingenus Pharmaceuticals, LLC Orlando, FL 32839-6408 Distributed by: Major Pharmaceuticals 17177 N Laurel Park Dr., Suite 233 Livonia, MI 48152 USA

D-0652-2021

Recall number: D-0652-2021
Initiated: July 02, 2021
Classification: Class II
Status: Terminated
Recalling firm: The Harvard Drug Group
Quantity: 504 Cartons of 50 count each; 372 Cartons of 100 count each

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0

Out of specification

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Dissolution Specification: Out of specification for dissolution during routine stability testing.

Code information

Lots: a)N00418 Exp. 09/2022, b) N00417 Exp. 09/2022

Distribution pattern

Distributed in OH and NJ