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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 93224

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

Open FDA event record

Event summary

Timeline bucket
October 23, 2023
Product types
Drug
Classifications
Class I
Statuses
Terminated
Recalling firm wording
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

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

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

Phenytoin Oral Suspension, USP, 100 mg/4 mL, packaged in packaged in 4 mL unit dose cups (NDC 0904-7079-24), 50 per case (NDC 0904-7079-57), Rx only, Major Pharmaceuticals Livonia, MI 48152

D-0153-2024
Recall number
D-0153-2024
Initiated
October 23, 2023
Classification
Class I
Status
Terminated
Quantity
3718 saleable units

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Failed Content Uniformity Specifications

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Content Uniformity Specifications

Code information

Lot# C00099, C00115 Exp. date: 07/31/2024; C00079 Exp. date: 12/31/2023

Distribution pattern

Nationwide in the USA