Reported Jul 15, 2020 · Terminated
Tecfidera (dimethyl fumarate) delayed-release capsules, 240 mg, 60-count bottle, Rx only, Manufactured by: Biogen Inc.,…
Biogen MA Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Biogen MA Inc. · 5000 Davis Dr · Research Triangle Park, NC · 27709
Is this the product you have?
- Tecfidera (dimethyl fumarate) delayed-release capsules, 240 mg, 60-count bottle, Rx only
- Manufactured byBiogen Inc., Cambridge, MA 02142, NDC 64406-006-02
- Lot codes and dates
Lot # SH0274Exp 2/2022
- Amount recalled
- 3,922 bottles
Where it was sold
Why it was recalled
cGMP deviations: one lot of the product was distributed to US Markets despite being rejected during in-process control.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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