Exact FDA event identifier

Event 91654

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

Event summary

Timeline bucket: February 06, 2023
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Alvogen, 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 112 mcg, 90 tablets per bottle, Rx Only, Manufactured by Lloyd Inc., Shenandoah, IA, 51601, Distributed by: Alvogen Inc, Pine Brook, NJ 07058, NDC 47781-654-90.

D-0353-2023

Recall number: D-0353-2023
Initiated: February 06, 2023
Classification: Class II
Status: Terminated
Recalling firm: Alvogen, Inc
Quantity: 21,276 bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0

Out of specification

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Sub-Potent Drug: Out of specification for assay at the 24 month interval.

Code information

Lot # HE02221, Exp. 05/2023

Distribution pattern

Nationwide and Puerto Rico.