Biogen MA Inc. recalls Vumerity (diroximel fumarate) delayed-release capsule, 231 mg, packaged in a) 106-count bottle, b)120-count bottle, Rx…
- Recall date
- December 9, 2020
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0148-2021
- FDA classification
- Class II
- Brand / firm
- Biogen MA Inc.
- Sold / distributed
- USA Nationwide
Why it was recalled
Failed dissolution specifications: out-of-specification test results observed during the buffer stage dissolution testing.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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
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