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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 85906

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

Open FDA event record

Event summary

Timeline bucket
June 23, 2020
Product types
Drug
Classifications
Class III
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

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

Tecfidera (dimethyl fumarate) delayed-release capsules, 240 mg, 60-count bottle, Rx only, Manufactured by: Biogen Inc., Cambridge, MA 02142, NDC 64406-006-02

D-1381-2020
Recall number
D-1381-2020
Initiated
June 23, 2020
Classification
Class III
Status
Terminated
Recalling firm
Biogen MA Inc.
Quantity
3,922 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
cGMP deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP deviations: one lot of the product was distributed to US Markets despite being rejected during in-process control.

Code information

Lot # SH0274, Exp 2/2022

Distribution pattern

Product was distributed to wholesalers/distributors in KY, OH & MS.