Exact FDA event identifier

Event 91751

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

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Event summary

Timeline bucket: February 23, 2023
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

Carbidopa and Levodopa Tablets, USP 25 mg/100 mg, 10x10 Unit Dose carton, Rx Only, Manufactured in Czech Republic by: Teva Czech Industries, s.r.o. Opava-Komarov, Czech Republic, Manufactured for: Teva Pharmaceuticals USA, Inc. Parsippany, NJ 07054, Packaged and Distributed by: Major Pharmaceuticals Indianapolis, IN 46268 USA. NDC 0904-7257-61, UPC 3 09047 25761 4

D-0432-2023

Recall number: D-0432-2023
Initiated: February 23, 2023
Classification: Class II
Status: Terminated
Recalling firm: The Harvard Drug Group
Quantity: 17,586 cartons

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

Packaging defect

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Packaging defect: observed packaging defect, blister packaging inadequately sealed.

Code information

Lot: M04145 Exp. 01/2024

Distribution pattern

Distributed Nationwide in the USA