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

Recall Number: D-0148-2021

Firm: Biogen MA Inc.

Classification: Class II

Status: Terminated

Report Date: 20201223

Initiation Date: 20201209

Termination Date: 20210917

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

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