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Tecfidera (dimethyl fumarate) delayed-release capsules, 240 mg, 60-count bottle, Rx only, Manufac...

FDA Recall #D-1381-2020 — Class III — June 23, 2020

Recall #D-1381-2020 Date: June 23, 2020 Classification: Class III Status: Terminated

Product Description

Tecfidera (dimethyl fumarate) delayed-release capsules, 240 mg, 60-count bottle, Rx only, Manufactured by: Biogen Inc., Cambridge, MA 02142, NDC 64406-006-02

Reason for Recall

cGMP deviations: one lot of the product was distributed to US Markets despite being rejected during in-process control.

Recalling Firm

Biogen MA Inc. — Research Triangle Park, NC

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Drugs

Product Quantity

3,922 bottles

Distribution

Product was distributed to wholesalers/distributors in KY, OH & MS.

Code Information

Lot # SH0274, Exp 2/2022

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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