Tecfidera delayed-release capsules recalled over manufacturing violations

Recall date

June 23, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Biogen MA Inc. recalls Tecfidera (dimethyl fumarate) delayed-release capsules, 240 mg, 60-count bottle, Rx only, Manufactured by: Biogen Inc.,…

Recall number

D-1381-2020

FDA classification

Class III

Brand / firm

Biogen MA Inc.

Sold / distributed

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

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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