Class II
Terminated
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
- Company
- Biogen Ma Inc.
- Recall Initiated
- December 9, 2020
- Posted
- December 23, 2020
- Recall Number
- D-0148-2021
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 5,307 bottles
- Firm Location
- Research Triangle Park, NC, United States
Reason for Recall
Failed dissolution specifications: out-of-specification test results observed during the buffer stage dissolution testing.
Distribution
USA Nationwide
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
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