FDADecember 9, 2020drug

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

biogen mabiogen

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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