Biogen MA recalls
FDA enforcement reports naming Biogen MA Inc. as the recalling firm.
- Recall reports
- 2
- Class I (serious)
- 0
- Most recent report
- Dec 23, 2020
- Dec 23, 2020Vumerity (diroximel fumarate) delayed-release capsule, 231 mg, packaged in a) 106-coun…Drug · Biogen MA Inc.Failed dissolution specifications: out-of-specification test results observed during the buffer stage dissolution testing.Class II
- Jul 15, 2020Tecfidera (dimethyl fumarate) delayed-release capsules, 240 mg, 60-count bottle, Rx onl…Drug · Biogen MA Inc.cGMP deviations: one lot of the product was distributed to US Markets despite being rejected during in-process control.Class III