Tecfidera (dimethyl fumarate) delayed-release capsules, 240 mg, 60-count bottle, Rx only, Manufactured by: Biogen Inc., Cambridge, MA 02142, NDC 64406-006-02
Reported: July 15, 2020 Initiated: June 23, 2020 #D-1381-2020
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
Reason for Recall
cGMP deviations: one lot of the product was distributed to US Markets despite being rejected during in-process control.
Details
- Recalling Firm
- Biogen MA Inc.
- Units Affected
- 3,922 bottles
- Distribution
- Product was distributed to wholesalers/distributors in KY, OH & MS.
- Location
- Research Triangle Park, NC
Frequently Asked Questions
What product was recalled? ▼
Tecfidera (dimethyl fumarate) delayed-release capsules, 240 mg, 60-count bottle, Rx only, Manufactured by: Biogen Inc., Cambridge, MA 02142, NDC 64406-006-02. Recalled by Biogen MA Inc.. Units affected: 3,922 bottles.
Why was this product recalled? ▼
cGMP deviations: one lot of the product was distributed to US Markets despite being rejected during in-process control.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 15, 2020. Severity: Low. Recall number: D-1381-2020.
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