Skip to content
Recall Observatory FDA recall evidence

Drug 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

D-0148-2021

December 09, 2020

Class II

Product summary

Firm
Biogen MA Inc.
Event
Event 86945
Status
Terminated
Classification
Class II
Quantity
5,307 bottles
Official record key
drug-enforcement:D-0148-2021

Official wording

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

Code information: Lot #: a) 101801, Exp 5/31/2021; 102826, Exp 6/21/2021; b) 101799, Exp 5/31/2021; 102362, Exp 6/21/2021

Distribution pattern: USA Nationwide

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    out-of-specification