FDAJune 23, 2020drug
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 recall recorded by the U.S. Food & Drug Administration.
The hazard
cGMP deviations: one lot of the product was distributed to US Markets despite being rejected during in-process control.
What to do
FDA enforcement status: Terminated
Brands named
biogen mabiogen
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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