Exact FDA event identifier

Event 62639

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

Event summary

Timeline bucket: July 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

Tizanidine (Generic for: Zanaflex), 4 mg, 90 Tablets per Bottle, Rx only, , Mfg By: Dr Reddys Labs Ltd., Bachepally, IN 500 - 090, Packaged and distributed by STAT Rx USA, Gainesville, GA, NDC 16590-221-90.

D-1427-2012

Recall number: D-1427-2012
Initiated: July 23, 2012
Classification: Class III
Status: Terminated
Recalling firm: Stat Rx USA
Quantity: 51 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; Some bottles of Tizanidine 4mg Tablets, had the incorrect manufacturer (Actavis) printed on the label.

Code information

Lot #: 28JN1272, Exp 02/15

Distribution pattern

Nationwide