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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 66288

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

Open FDA event record

Event summary

Timeline bucket
March 18, 2013
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Boehringer Ingelheim Roxane 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

Oxcarbazepine Tablets, 150 mg, packaged in a) 10 x 10 count Unit-Dose Tablets in blisters packaged in a carton (NDC 0054-0097-20) and b) 100-count bottle (NDC 0054-0097-25), Rx only, Roxane Laboratories, Inc., Columbus, Ohio 43216

D-343-2014
Recall number
D-343-2014
Initiated
March 18, 2013
Classification
Class III
Status
Terminated
Quantity
8,550 cartons and 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: The firm discovered out of specification results for assay and the extended investigation revealed the potential for lower weight tablets.

Code information

Lot #: a) 259666A, Exp. MAR 2014; b) 259666B, Exp. MAR 2014

Distribution pattern

Nationwide and Puerto Rico