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) 101801Exp 5/31/2021102826Exp 6/21/2021b) 101799Exp 5/31/2021102362Exp 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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