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

FDA recall notice · announced July 15, 2020 · Biogen Ma

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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.

Notes

Distribution: Product was distributed to wholesalers/distributors in KY, OH & MS.
Lot/code information: Lot # SH0274, Exp 2/2022
Quantity: 3,922 bottles
Status: Terminated
Products in this recall event:
- Tecfidera (dimethyl fumarate) delayed-release capsules, 240 mg, 60-count bottle, Rx only, Manufactured by: Biogen Inc., Cambridge, MA 02142, NDC 64406-006-02 (D-1381-2020)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.