Biogen MA Inc.: Drug Recall
Recall #D-0148-2021 · 12/09/2020
Class II: Risk
Recall Details
- Recall Number
- D-0148-2021
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- Biogen MA Inc.
- Status
- Terminated
- Date Initiated
- 12/09/2020
- Location
- Research Triangle Park, NC, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5,307 bottles
Reason for Recall
Failed dissolution specifications: out-of-specification test results observed during the buffer stage dissolution testing.
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
Distribution Pattern
USA Nationwide
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.