Exact FDA event identifier

Event 64109

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

Event summary

Timeline bucket: December 18, 2012
Product types: Drug
Classifications: Class III
Statuses: Terminated
Recalling firm wording: Belmora LLC

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

Flanax (aluminum hydroxide, magnesium hydroxide, and simethicone) Fast Acting Antacid, 200 mg/200 mg/20 mg, 12 fl oz (355 mL) bottles, Distributed by: Belmora LLC, PO Box 3063, Arlington, VA 22203, UPC 8 53030 00209 0, NDC 27854.101.01.

D-136-2013

Recall number: D-136-2013
Initiated: December 18, 2012
Classification: Class III
Status: Terminated
Recalling firm: Belmora LLC
Quantity: 17,996 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Defective Container: Product lacks tamper evident breakaway band on cap.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Defective Container: Product lacks tamper evident breakaway band on cap.

Code information

Lot #: 1321, 1322, 1323, and 1324

Distribution pattern

Nationwide