Exact FDA event identifier

Event 92524

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

Open FDA event record

Event summary

Timeline bucket: June 16, 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

Tramadol Hydrochloride Tablets, USP 50 mg, Unit Dose 100-Count Tablets Rx only, Manufactured by: Sun Pharmaceutical Industries Ltd. Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), India. Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Distributed by: Major Pharmaceuticals Livonia, MI 48152 USA, NDC 0904-7179-61

D-0878-2023

Recall number: D-0878-2023
Initiated: June 16, 2023
Classification: Class II
Status: Terminated
Recalling firm: The Harvard Drug Group
Quantity: 3876 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: blister packaging inadequately sealed.

Code information

Lot #: M04343, Exp. 04/2024

Distribution pattern

Nationwide in the U.S.