Exact FDA event identifier

Event 87372

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

Event summary

Timeline bucket: February 26, 2021
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

Buprenorphine and Naloxone Sublingual Film 2mg/0.5mg, 30 pouches each containing 1 sublingual film, Distributed by: Alvogen, Inc. Pine Brook, NJ 07058 USA, NDC 47781-355-03

D-0649-2021

Recall number: D-0649-2021
Initiated: February 26, 2021
Classification: Class II
Status: Terminated
Recalling firm: Alvogen, Inc
Quantity: 9,696 cartons

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: Out of specification for assay of naloxone and buprenorphine (low)

Code information

Lot #: 36924, Exp 6/2021

Distribution pattern

USA nationwide.