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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 63017

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

Open FDA event record

Event summary

Timeline bucket
August 27, 2012
Product types
Drug
Classifications
Class I
Statuses
Terminated
Recalling firm wording
Samantha Lynn, 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

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

Reumofan Plus Tablets, 30-count bottle per Box, (remaining label information in Spanish)

D-063-2013
Recall number
D-063-2013
Initiated
August 27, 2012
Classification
Class I
Status
Terminated
Recalling firm
Samantha Lynn, Inc
Quantity
25,888 Boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Marketed without an approved NDA/ANDA: Samantha Lynn Inc. is recalling Reumofan Plus Tablets because it contains undeclared drug ingredients making it an unapproved drug.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Marketed without an approved NDA/ANDA: Samantha Lynn Inc. is recalling Reumofan Plus Tablets because it contains undeclared drug ingredients making it an unapproved drug.

Code information

all lots within expiry through 2016

Distribution pattern

Nationwide and Canada, Australia, Germany, Brazil, Austria, United Kingdom, India, Chile, Switzerland, Thailand, Japan