Recalls / Class II
Class IID-0148-2021
Product
Vumerity (diroximel fumarate) delayed-release capsule, 231 mg, packaged in a) 106-count bottle, b)120-count bottle, Rx only, Manufactured for: Biogen Inc., Cambridge, MA 02142, NDC 64406-020-01
- Brand name
- Vumerity
- Generic name
- Diroximel Fumarate
- Active ingredient
- Diroximel Fumarate
- Route
- Oral
- NDC
- 64406-020
- FDA application
- NDA211855
- Affected lot / code info
- Lot #: a) 101801, Exp 5/31/2021; 102826, Exp 6/21/2021; b) 101799, Exp 5/31/2021; 102362, Exp 6/21/2021
Why it was recalled
Failed dissolution specifications: out-of-specification test results observed during the buffer stage dissolution testing.
Recalling firm
- Firm
- Biogen MA Inc.
- Manufacturer
- Biogen Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 5000 Davis Dr, N/A, Research Triangle Park, North Carolina 27709
Distribution
- Quantity
- 5,307 bottles
- Distribution pattern
- USA Nationwide
Timeline
- Recall initiated
- 2020-12-09
- FDA classified
- 2020-12-14
- Posted by FDA
- 2020-12-23
- Terminated
- 2021-09-17
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0148-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.