Recalls / Class III
Class IIID-1381-2020
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
- Brand name
- Tecfidera
- Generic name
- Dimethyl Fumarate
- Active ingredient
- Dimethyl Fumarate
- Route
- Oral
- NDCs
- 64406-005, 64406-007, 64406-006
- FDA application
- NDA204063
- Affected lot / code info
- Lot # SH0274, Exp 2/2022
Why it was recalled
cGMP deviations: one lot of the product was distributed to US Markets despite being rejected during in-process control.
Recalling firm
- Firm
- Biogen MA Inc.
- Manufacturer
- Biogen Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 5000 Davis Dr, Research Triangle Park, North Carolina 27709
Distribution
- Quantity
- 3,922 bottles
- Distribution pattern
- Product was distributed to wholesalers/distributors in KY, OH & MS.
Timeline
- Recall initiated
- 2020-06-23
- FDA classified
- 2020-07-09
- Posted by FDA
- 2020-07-15
- Terminated
- 2021-02-11
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1381-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.