Tecfidera (dimethyl fumarate) delayed-release capsules, 240 mg, 60-count bottle, Rx only, Manufactured by: Biogen Inc., Cambridge, MA 02142, NDC 64406-006-02
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot # SH0274, Exp 2/2022
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Biogen MA Inc.
- Reason for Recall:
- cGMP deviations: one lot of the product was distributed to US Markets despite being rejected during in-process control.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full 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
Product Codes/Lot Numbers:
Lot # SH0274, Exp 2/2022
Distribution:
Distributed in: KY, OH, MS
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-1381-2020
Related Recalls
Class I - Dangerous
Failed dissolution specifications: out-of-specification test results observed during the buffer stage dissolution testing.