Drug 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
D-0148-2021
Product summary
- Firm
- Biogen MA Inc.
- Event
- Event 86945
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5,307 bottles
- Official record key
drug-enforcement:D-0148-2021
Official wording
Reason: Failed dissolution specifications: out-of-specification test results observed during the buffer stage dissolution testing.
Code information: Lot #: a) 101801, Exp 5/31/2021; 102826, Exp 6/21/2021; b) 101799, Exp 5/31/2021; 102362, Exp 6/21/2021
Distribution pattern: USA Nationwide
Derived failure modes
-
Potency or specification failure
out-of-specification