FDA recall D-0148-2021

Product

Vumerity (diroximel fumarate) delayed-release capsule, 231 mg, packaged in a) 106-count bottle, b)120-count bottle, Rx only, Manufactured for: Biogen Inc., Cambridge, MA 02142, NDC 64406-020-01

Reason for recall

Failed dissolution specifications: out-of-specification test results observed during the buffer stage dissolution testing.

Distribution

USA Nationwide

Key facts

Status

Terminated

Initiation date

2020-12-09

Report date

2020-12-23

Termination date

2021-09-17

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-0148-2021