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Biogen MA Inc.

Biogen MA Inc. Recalls

All product recalls associated with Biogen MA Inc..

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Recall Summary

Total Recalls

Past Year

Class I (Serious)

Most Recent

Dec 2020

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–2 of 2 recalls

Vumerity (Biogen) – dissolution specification failure (2020)

Failed dissolution specifications: out-of-specification test results observed during the buffer stage dissolution testing.

Class IIModerate

FDADec 9, 2020Nationwide• Biogen MA Inc.

Tecfidera 240mg Capsules (Biogen) – Manufacturing deviation (2020)

cGMP deviations: one lot of the product was distributed to US Markets despite being rejected during in-process control.

Class IIILow

FDAJun 23, 2020IN, KY, MS +1 more• Biogen MA Inc.