Drug 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
D-1381-2020
Product summary
- Firm
- Biogen MA Inc.
- Event
- Event 85906
- Status
- Terminated
- Classification
- Class III
- Quantity
- 3,922 bottles
- Official record key
drug-enforcement:D-1381-2020
Official wording
Reason: cGMP deviations: one lot of the product was distributed to US Markets despite being rejected during in-process control.
Code information: Lot # SH0274, Exp 2/2022
Distribution pattern: Product was distributed to wholesalers/distributors in KY, OH & MS.
Derived failure modes
-
Manufacturing or process control
cGMP deviations