Exact FDA event identifier

Event 63659

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

Event summary

Timeline bucket: August 23, 2012
Product types: Drug
Classifications: Class III
Statuses: Terminated
Recalling firm wording: Stat Rx USA

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

Venlafaxine ER 150mg, 30 Tabs bottle, Generic for: Effexor, Packaged and Distributed by: Stat Rx USA, LLC, Gainesville, GA 30501 NDC 42549-684-30

D-051-2013

Recall number: D-051-2013
Initiated: August 23, 2012
Classification: Class III
Status: Terminated
Recalling firm: Stat Rx USA
Quantity: 5 bottles

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

Labeling: Label Mix-up

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Labeling: Label Mix-up: Product was incorrectly labeled,"Tabs" instead of "Capsules."

Code information

Lot # A00984 Exp. 01/14

Distribution pattern

GA and TN.