Biogen Ma recalls
Biogen Ma appears in 2 official U.S. recall notices indexed by RecallRadar, most recently on 2020-12-23.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 2 |
|---|---|
| Published | 2020-07-15 to 2020-12-23 |
| By agency | FDA Drug (2) |
| By classification | Class II (1), Class III (1) |
| By status | terminated (2) |
| Distribution named in notices | KY, MS, OH, US |
Recalls
- Vumerity (diroximel fumarate) delayed-release capsule, 231 mg, packaged in a) 106-count bottle, b)120-count bottle, Rx only, Manufactured f…
FDA Drug · Class II · 2020-12-23 · Biogen Ma
Reason: Failed dissolution specifications: out-of-specification test results observed during the buffer stage dissolution testing. - Tecfidera (dimethyl fumarate) delayed-release capsules, 240 mg, 60-count bottle, Rx only, Manufactured by: Biogen Inc., Cambridge, MA 02142…
FDA Drug · Class III · 2020-07-15 · Biogen Ma
Reason: cGMP deviations: one lot of the product was distributed to US Markets despite being rejected during in-process control.