December 2020 FDA Recall Vumerity by Biogen Ma Inc.
D-0148-2021 - Failed dissolution specifications

This Class II drug recall was voluntarily initiated by Biogen Ma Inc. on December 9, 2020 for the product Vumerity. The FDA reported the reason for recall as failed dissolution specifications. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0148-2021

Reason for Recall
Failed dissolution specifications: out-of-specification test results observed during the buffer stage dissolution testing.
Initiated
12-09-2020
Reported
12-23-2020
Quantity
5,307 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86945
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Biogen MA Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-17-2021
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

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

Affected Packages Involved in this Recall

64406-020-01 Vumerity
64406-020-03 Vumerity
64406-020-05 Vumerity
64406-020-07 Vumerity