Product: 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.
Recall initiated: 20200623
Status: Terminated
Classification: Class III
Recall type: Voluntary: Firm initiated