Tecfidera (dimethyl fumarate) delayed-release capsules, 240 mg, 60-count bottle recall — FDA D-1381-2020
cGMP deviations: one lot of the product was distributed to US Markets despite being rejected during in-process control.
Overview of recall records associated with Biogen MA Inc., including dates, categories and classifications where available.
Classification mix: Class III: 1.
cGMP deviations: one lot of the product was distributed to US Markets despite being rejected during in-process control.
This page summarizes recall records in which the official source identifies Biogen MA Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.