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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 65582

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

Open FDA event record

Event summary

Timeline bucket
June 04, 2013
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
West-Ward Pharmaceutical Corp.

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

VersaPharm Incorporated, Ethambutol Hydrochloride Tablets, USP 400 mg 60 tablets, Rx Only, Mfd. for VersaPharm Incorporated Marietta, GA 30065-1509; Mfd. by: West-ward Pharmaceuticals Corp., Eatontown, NJ 07724 NDC 61748-014-06,

D-839-2013
Recall number
D-839-2013
Initiated
June 04, 2013
Classification
Class II
Status
Terminated
Quantity
118 bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Out of Specification

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Discoloration: Ethambutol HCl Tablets 400 mg is being recalled due to a Out of Specification result for description testing for a surface defect of ink.

Code information

Lot 69968B 03/14

Distribution pattern

GA