Why it was recalled
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
Lot numbers, UPCs & expiration codes
Lot #: a) 101801, Exp 5/31/2021; 102826, Exp 6/21/2021; b) 101799, Exp 5/31/2021; 102362, Exp 6/21/2021
Where it was sold
USA Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0148-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 9, 2020
- FDA report date
- Dec 23, 2020
- Quantity
- 5,307 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Biogen MA Inc.
Original FDA data
Every field from FDA enforcement report D-0148-2021, exactly as published.
Show all FDA fields
- City
- Research Triangle Park
- State
- NC
- Status
- Terminated
- Country
- United States
- Event ID
- 86945
- Address
- 5000 Davis Dr
- 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
- Postal code
- 27709
- Report date
- Dec 23, 2020
- Product type
- Drugs
- Recall number
- D-0148-2021
- Classification
- Class II
- Recalling firm
- Biogen MA Inc.
- Product quantity
- 5,307 bottles
- Termination date
- Sep 17, 2021
- Reason for recall
- Failed dissolution specifications: out-of-specification test results observed during the buffer stage dissolution testing.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Recall initiation date
- Dec 9, 2020
- Initial firm notification
- Letter
- Center classification date
- Dec 14, 2020