Exact FDA event identifier

Event 94132

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

Event summary

Timeline bucket: March 04, 2024
Product types: Drug
Classifications: Class III
Statuses: Terminated
Recalling firm wording: Novitium Pharma LLC

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

Digoxin Tablets, USP 125mcg, (0.125 mg), 1000-count bottle, Rx Only, Manufactured by: Novitium Pharma LLC., 70 Lake Drive, East Windsor, New Jersey 08520, NDC 70954-201-20

D-0389-2024

Recall number: D-0389-2024
Initiated: March 04, 2024
Classification: Class III
Status: Terminated
Recalling firm: Novitium Pharma LLC
Quantity: 3,940 1000-count bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Cross Contamination with Other Products:(mycophenolate mofetil).

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Cross Contamination with Other Products:(mycophenolate mofetil).

Code information

Lot #: M23172A, Exp 01/31/2025

Distribution pattern

Nationwide in the USA