Class II · Moderate risk
Vumerity (diroximel fumarate)
Failed dissolution specifications: out-of-specification test results observed during the buffer stage dissolution testing.
Tecfidera (dimethyl fumarate)
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
cGMP deviations: one lot of the product was distributed to US Markets despite being rejected during in-process control.
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
What 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
Affected NDC
64406-0006-02
Compare with the code on your package — it is the most precise check available.
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Tecfidera dimethyl fumarate NDC 64406-0006 |
240 mg/1 | Capsule Oral |
Biogen Inc. | Rx |
- Recalling firm
- Biogen MA Inc.
- NDC code
- 64406-006-02
- Origin
- NC, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1381-2020 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other recalls by Biogen MA Inc.
All 2020 recallsOther cgmp deviation recalls from 2020
All cgmp deviation recalls
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