Biogen MA Inc. recalls Tecfidera (dimethyl fumarate) delayed-release capsules, 240 mg, 60-count bottle, Rx only, Manufactured by: Biogen Inc.,
Recalled July 15, 2020 · FDA recall D-1381-2020 · Biogen MA
Hazard
cGMP deviations: one lot of the product was distributed to US Markets despite being rejected during in-process control. · FDA Class III
Units
3,922 bottles
Sold at
Product was distributed to wholesalers/distributors in KY, OH & MS.
Description
cGMP deviations: one lot of the product was distributed to US Markets despite being rejected during in-process control.
Product
Tecfidera (dimethyl fumarate) delayed-release capsules, 240 mg, 60-count bottle, Rx only, Manufactured by: Biogen Inc., Cambridge, MA 02142, NDC 64406-006-02
Manufacturer(s)
Biogen MA Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →