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Vumerity (diroximel fumarate) delayed-release capsule, 231 mg, packaged in a) 106-count bottle, ...

FDA Recall #D-0148-2021 — Class II — December 9, 2020

Recall #D-0148-2021 Date: December 9, 2020 Classification: Class II Status: Terminated

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

Reason for Recall

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

Recalling Firm

Biogen MA Inc. — Research Triangle Park, NC

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

5,307 bottles

Distribution

USA Nationwide

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

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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