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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 83460

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

Open FDA event record

Event summary

Timeline bucket
April 24, 2019
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
MAJOR PHARMACEUTICALS

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

DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS, USP Tablets, 250 mg, 100 count-unit dose carton, RX only, Manufactured by Dr. Reddy's Laboratories Ltd. Bachupally - 500 090 India. Distributed by: Major Pharmaceuticals 17177 N Laurel Park Dr., Suite 233 Livonia, MI 48152. NDC # 0904-6363-61.

D-1583-2019
Recall number
D-1583-2019
Initiated
April 24, 2019
Classification
Class II
Status
Terminated
Recalling firm
MAJOR PHARMACEUTICALS
Quantity
828 100-count unit dose cartons

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
cGMP deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations.

Code information

Lot# M02250 EXP 10/2020.

Distribution pattern

Nationwide in the USA