Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 83368

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

Open FDA event record

Event summary

Timeline bucket
July 18, 2019
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Ucb, 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

Keppra (levetiracetam) 1000 mg tablets, 60 tablets per bottle, Rx only, Manufactured for UCB, Inc. Smyrna, GA 30080, NDC 50474-597-66.

D-1838-2019
Recall number
D-1838-2019
Initiated
July 18, 2019
Classification
Class II
Status
Terminated
Recalling firm
Ucb, Inc
Quantity
2088 bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Failed Dissolution Specifications

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Dissolution Specifications.

Code information

Lot: 908946 Exp. 02/2022

Distribution pattern

TN

Field note

Send feedback

We'll only use this to respond to your feedback.