Vumerity Capsule
FDA Recall NDC 64406-020
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Vumerity (NDC 64406-020). A significant event, classified as Class II, was initiated on Dec 09, 2020 by Biogen Inc.. The reported reason for this action was: "Failed dissolution specifications: out-of-specification test results observed during the buffer stage dissolution testing."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Failed dissolution specifications: out-of-specification test results observed during the buffer stage dissolution testing.
Dec 09, 2020
Dec 23, 2020
5,307 bottles
Recall Profile & Regulatory Data
Event ID
86945
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Biogen MA Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA Nationwide
Termination Date
Sep 17, 2021
Product Description
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
64406-020-01Product
64406-020-03Product
64406-020-05Product
64406-020-07Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
