Biogen MA Recalls
2 recalls on record · July 15, 2020 to December 23, 2020 · Drugs
December 23, 2020DrugsFDA
Biogen MA Inc. recalls Vumerity (diroximel fumarate) delayed-release capsule, 231 mg, packaged in a) 106-count bottle, b)120-count bottle, Rx
Hazard: Failed dissolution specifications: out-of-specification test results observed during the buffer stage dissolution testing.
July 15, 2020DrugsFDA
Biogen MA Inc. recalls Tecfidera (dimethyl fumarate) delayed-release capsules, 240 mg, 60-count bottle, Rx only, Manufactured by: Biogen Inc.,
Hazard: cGMP deviations: one lot of the product was distributed to US Markets despite being rejected during in-process control.