Exact FDA event identifier

Event 63988

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

Event summary

Timeline bucket: December 28, 2012
Product types: Drug
Classifications: Class I
Statuses: Terminated
Recalling firm wording: Advance Pharmaceutical Inc

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

Rugby NATURAL IRON SUPPLEMENT Ferrous Sulfate, 5 gr (325 mg), 100 TABLETS, Mfd for: RUGBY LABORATORIES, INC. DULUTH, GEORGIA 30097 UPC 0 0536-5890-013

D-601-2013

Recall number: D-601-2013
Initiated: December 28, 2012
Classification: Class I
Status: Terminated
Recalling firm: Advance Pharmaceutical Inc
Quantity: 19,944 bottles

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

Labeling; Label Mixup

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Labeling; Label Mixup; bottles of Ferrous Sulfate actually contains Meclizine HCl (indicated for motion sickness)

Code information

Lot 12G468, Exp. 07/2014.

Distribution pattern

Nationwide