FDA recall D-1381-2020

Product

Tecfidera (dimethyl fumarate) delayed-release capsules, 240 mg, 60-count bottle, Rx only, Manufactured by: Biogen Inc., Cambridge, MA 02142, NDC 64406-006-02

Reason for recall

cGMP deviations: one lot of the product was distributed to US Markets despite being rejected during in-process control.

Distribution

Product was distributed to wholesalers/distributors in KY, OH & MS.

Key facts

Status

Terminated

Initiation date

2020-06-23

Report date

2020-07-15

Termination date

2021-02-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

Research Triangle Park, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1381-2020