Drug recall D-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
Reason for recall
Failed dissolution specifications: out-of-specification test results observed during the buffer stage dissolution testing.
Lots and codes
Lot #: a) 101801, Exp 5/31/2021; 102826, Exp 6/21/2021; b) 101799, Exp 5/31/2021; 102362, Exp 6/21/2021
Recall details
- Recalling firm
- Biogen MA Inc., Research Triangle Park, NC
- Quantity
- 5,307 bottles
- Distribution
- USA Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- December 9, 2020
- Terminated
- September 17, 2021
Related products
- Vumerity – drug information
- NDC 64406-020 Vumerity · Diroximel Fumarate 231 mg/1 · Biogen Inc.