Exact FDA event identifier

Event 67399

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

Event summary

Timeline bucket: January 14, 2014
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Mylan Pharmaceuticals 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

Device root-cause evidence is not applicable to this event. No grouped product has the official product type device; this is not an unavailable-enrichment finding.

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

Levothyroxine Sodium Tablets, USP, 200 mcg, 100-count bottle, Rx only, Distributed by Mylan Pharmaceuticals Inc. Morgantown, WV 26505, NDC 0378-1819-01

D-1084-2014

Recall number: D-1084-2014
Initiated: January 14, 2014
Classification: Class II
Status: Terminated
Recalling firm: Mylan Pharmaceuticals Inc.
Quantity: 138,970 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: Assay results obtained during stability testing for Levothyroxine Sodium Tablets, USP were below specification.

Code information

Lot 3037531 EXP 03/14 Lot 3038284 EXP 04/14

Distribution pattern

Nationwide.