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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 67162

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

Open FDA event record

Event summary

Timeline bucket
December 23, 2013
Product types
Drug
Classifications
Class I
Statuses
Terminated
Recalling firm wording
Deseo Rebajar

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

Burn 7 Capsules, supplied in 30 capsules bottle

D-1351-2014
Recall number
D-1351-2014
Initiated
December 23, 2013
Classification
Class I
Status
Terminated
Recalling firm
Deseo Rebajar
Quantity
120 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Marketed Without an Approved NDA/ANDA: Undeclared sibutramine and phenolphthalein in Burn 7 dietary supplement

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Marketed Without an Approved NDA/ANDA: Undeclared sibutramine and phenolphthalein in Burn 7 dietary supplement

Code information

MFD: 07.18.2013, EXP: 07.17.2015

Distribution pattern

Puerto Rico only