Reported Dec 23, 2020 · Terminated

Vumerity (diroximel fumarate) delayed-release capsule, 231 mg, packaged in a) 106-count bottle, b)120-count bottle, Rx…

Biogen MA Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Biogen MA Inc. · 5000 Davis Dr · Research Triangle Park, NC · 27709

Is this the product you have?

  • Vumerity (diroximel fumarate) delayed-release capsule, 231 mg, packaged in a) 106-count bottle, b)120-count bottle, Rx only
  • Manufactured forBiogen Inc., Cambridge, MA 02142, NDC 64406-020-01
Lot codes and dates
    • Lot #: a) 101801
    • Exp 5/31/2021
    • 102826
    • Exp 6/21/2021
    • b) 101799
    • Exp 5/31/2021
    • 102362
    • Exp 6/21/2021
Amount recalled
5,307 bottles

Where it was sold

  • Nationwide

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Sep 17, 2021 · Data as of Sep 19, 5:06 PM UTC

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