Biogen MA Inc. recalls Vumerity (diroximel fumarate) delayed-release capsule, 231 mg, packaged in a) 106-count bottle, b)120-count bottle, Rx
Recalled December 23, 2020 · FDA recall D-0148-2021 · Biogen MA
Hazard
Failed dissolution specifications: out-of-specification test results observed during the buffer stage dissolution testing. · FDA Class II
Units
5,307 bottles
Sold at
USA Nationwide
Description
Failed dissolution specifications: out-of-specification test results observed during the buffer stage dissolution testing.
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
Manufacturer(s)
Biogen MA Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →