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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 63080

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

Open FDA event record

Event summary

Timeline bucket
September 04, 2012
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Apace KY 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

Enalapril Maleate Tablet, USP 5mg 30 Tablet bottle, Rx, Apace Packaging LLC, Ft. Run, KY 42133, NDC 15338-211-30

D-1683-2012
Recall number
D-1683-2012
Initiated
September 04, 2012
Classification
Class III
Status
Terminated
Recalling firm
Apace KY LLC
Quantity
81,516 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Labeling Illegible: Some bottles labels have incomplete NDC numbers and missing strength.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Labeling Illegible: Some bottles labels have incomplete NDC numbers and missing strength.

Code information

Lot: DL11600 Exp Date: 06/13

Distribution pattern

Nationwide