D-0148-2021 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- December 23, 2020
- Initiation Date
- December 9, 2020
- Termination Date
- September 17, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5,307 bottles
Product Description
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.
Distribution Pattern
USA Nationwide
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