Tecfidera Capsule
FDA Recall NDC 64406-005
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Tecfidera (NDC 64406-005). A significant event, classified as Class III, was initiated on Jun 23, 2020 by Biogen Inc.. The reported reason for this action was: "cGMP deviations: one lot of the product was distributed to US Markets despite being rejected during in-process control."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class III Terminated
cGMP deviations: one lot of the product was distributed to US Markets despite being rejected during in-process control.
Jun 23, 2020
Jul 15, 2020
3,922 bottles
Recall Profile & Regulatory Data
Event ID
85906
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Biogen MA Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed to wholesalers/distributors in KY, OH & MS.
Termination Date
Feb 11, 2021
Product Description
Tecfidera (dimethyl fumarate) delayed-release capsules, 240 mg, 60-count bottle, Rx only, Manufactured by: Biogen Inc., Cambridge, MA 02142, NDC 64406-006-02
Batch or Lot Expiration Information
Lot# SH0274, Exp 2/2022
Affected Packages Involved in this Recall
64406-007-03Product
64406-005-01Product
64406-006-02Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
