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MS Medication Recalled

07/17/2020

Biogen is recalling a single lot of Tecfidera that was distributed despite being rejected during in-process control checks during production, according to the July 15, 2020, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects Tecfidera (dimethyl fumarate) delayed-release capsules, 60-count bottles (NDC 64406-006-02), from lot SH0274 (Exp. 2/22). Nearly 4000 bottles were distributed to wholesalers in Kentucky, Ohio, and Mississippi.

Biogen voluntarily initiated the recall June 23, 2020. The FDA designated the recall Class III on July 9, 2020, suggesting use of the affected capsules is not likely to cause harm.

Tecfidera is a prescription medicine used to treat relapsing forms of multiple sclerosis in adults.

—Jolynn Tumolo

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MS Medication Recalled

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