FDA-Drug2020-07-15Class III
Tecfidera (dimethyl fumarate) delayed-release capsules, 240 mg, 60-count bottle, Rx only, Manufactured by: Biogen Inc., Cambridge, MA 02142, NDC 64406-006-02
Biogen MA Inc.
Hazard
cGMP deviations: one lot of the product was distributed to US Markets despite being rejected during in-process control.
Sold states
Product was distributed to wholesalers/distributors in KY, OH & MS.
Affected count
3,922 bottles
Manufactured in
5000 Davis Dr, Research Triangle Park, NC, United States
Products
Tecfidera (dimethyl fumarate) delayed-release capsules, 240 mg, 60-count bottle, Rx only, Manufactured by: Biogen Inc., Cambridge, MA 02142, NDC 64406-006-02
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1381-2020Don't want to check this manually?
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