Why it was recalled
cGMP deviations: one lot of the product was distributed to US Markets despite being rejected during in-process control.
Product description
Tecfidera (dimethyl fumarate) delayed-release capsules, 240 mg, 60-count bottle, Rx only, Manufactured by: Biogen Inc., Cambridge, MA 02142, NDC 64406-006-02
Lot numbers, UPCs & expiration codes
Lot # SH0274, Exp 2/2022
Where it was sold
Product was distributed to wholesalers/distributors in KY, OH & MS.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1381-2020
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jun 23, 2020
- FDA report date
- Jul 15, 2020
- Quantity
- 3,922 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Biogen MA Inc.
Original FDA data
Every field from FDA enforcement report D-1381-2020, exactly as published.
Show all FDA fields
- City
- Research Triangle Park
- State
- NC
- Status
- Terminated
- Country
- United States
- Event ID
- 85906
- Address
- 5000 Davis Dr
- Code information
- Lot # SH0274, Exp 2/2022
- Postal code
- 27709
- Report date
- Jul 15, 2020
- Product type
- Drugs
- Recall number
- D-1381-2020
- Classification
- Class III
- Recalling firm
- Biogen MA Inc.
- Product quantity
- 3,922 bottles
- Termination date
- Feb 11, 2021
- Reason for recall
- cGMP deviations: one lot of the product was distributed to US Markets despite being rejected during in-process control.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Tecfidera (dimethyl fumarate) delayed-release capsules, 240 mg, 60-count bottle, Rx only, Manufactured by: Biogen Inc., Cambridge, MA 02142, NDC 64406-006-02
- Distribution pattern
- Product was distributed to wholesalers/distributors in KY, OH & MS.
- Recall initiation date
- Jun 23, 2020
- Initial firm notification
- Letter
- Center classification date
- Jul 9, 2020