FDAFDA · Food and drugs·Recall number D-0148-2021
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
Published December 23, 2020 · Recall initiated: December 9, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed dissolution specifications: out-of-specification test results observed during the buffer stage dissolution testing.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- VUMERITY
- Manufacturer
- Biogen MA Inc.
- Distributor
- USA Nationwide
- UPC
- 0364406020032
- Lot
- Lot #: a) 101801, Exp 5/31/2021; 102826, Exp 6/21/2021; b) 101799, Exp 5/31/2021; 102362, Exp 6/21/2021
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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