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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 65954

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

Open FDA event record

Event summary

Timeline bucket
February 26, 2013
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Sanofi-Synthelabo

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

Rifadin (rifampin) capsules, USP, 150 mg, 100-count capsules per bottle, Manufactured by: Fabrique par Sanofi-Aventis Canada Inc., Laval, Quebec, Canada H7L4A8, DIN # 02091887

D-886-2013
Recall number
D-886-2013
Initiated
February 26, 2013
Classification
Class II
Status
Terminated
Recalling firm
Sanofi-Synthelabo
Quantity
998 Bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent Drug: During review of retain samples, the manufacturer observed low fill in some capsules, which was related to an issue detected with the encapsulating equipment.

Code information

Lot # 3099036, Exp 03/2014

Distribution pattern

Canada