Exact FDA event identifier

Event 86945

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

Open FDA event record

Event summary

Timeline bucket: December 09, 2020
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Biogen MA 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

Vumerity (diroximel fumarate) delayed-release capsule, 231 mg, packaged in a) 106-count bottle, b)120-count bottle, Rx only, Manufactured for: Biogen Inc., Cambridge, MA 02142, NDC 64406-020-01

D-0148-2021

Recall number: D-0148-2021
Initiated: December 09, 2020
Classification: Class II
Status: Terminated
Recalling firm: Biogen MA Inc.
Quantity: 5,307 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

Failed dissolution specifications: out-of-specification test results observed during the buffer stage dissolution testing.

Code information

Lot #: a) 101801, Exp 5/31/2021; 102826, Exp 6/21/2021; b) 101799, Exp 5/31/2021; 102362, Exp 6/21/2021

Distribution pattern

USA Nationwide