FDA-Drug2020-12-23Class II
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
Biogen MA Inc.
Hazard
Failed dissolution specifications: out-of-specification test results observed during the buffer stage dissolution testing.
Sold states
USA Nationwide
Affected count
5,307 bottles
Manufactured in
5000 Davis Dr, N/A, Research Triangle Park, NC, United States
Products
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 notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0148-2021Don't want to check this manually?
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