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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 92894

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

Open FDA event record

Event summary

Timeline bucket
August 17, 2023
Product types
Drug
Classifications
Class III
Statuses
Completed
Recalling firm wording
Lundbeck 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

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

Sabril (vigabatrin) for Oral Solution, 500 mg, 50 Packets, Rx only, Manufactured by: Patheon, Cincinnati, OH 45237, NDC 67386-211-65

D-1142-2023
Recall number
D-1142-2023
Initiated
August 17, 2023
Classification
Class III
Status
Completed
Recalling firm
Lundbeck LLC
Quantity
10,543 cartons

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Cross contamination with other products

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Cross contamination with other products

Code information

Lot#: 3207333A, 3207334A, Exp 03/2027; 3214707A, 3214709A, 3214710A, Exp 02/2028 .

Distribution pattern

Nationwide within the U.S.