FDAFDA · Food and drugs·Recall number D-1381-2020
Tecfidera (dimethyl fumarate) delayed-release capsules, 240 mg, 60-count bottle, Rx only, Manufactured by: Biogen Inc., Cambridge, MA 02142, NDC 64406-006-02
Published July 15, 2020 · Recall initiated: June 23, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
cGMP deviations: one lot of the product was distributed to US Markets despite being rejected during in-process control.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- TECFIDERA
- Manufacturer
- Biogen MA Inc.
- Distributor
- Product was distributed to wholesalers/distributors in KY, OH & MS.
- UPC
- 0364406005015
- Lot
- Lot # SH0274, Exp 2/2022
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.