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

Recall Number: D-1381-2020

Firm: Biogen MA Inc.

Classification: Class III

Status: Terminated

Report Date: 20200715

Initiation Date: 20200623

Termination Date: 20210211

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

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