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
Reported: December 23, 2020 Initiated: December 9, 2020 #D-0148-2021
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.
Details
- Recalling Firm
- Biogen MA Inc.
- Units Affected
- 5,307 bottles
- Distribution
- USA Nationwide
- Location
- Research Triangle Park, NC
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Biogen MA Inc.. Units affected: 5,307 bottles.
Why was this product recalled? ▼
Failed dissolution specifications: out-of-specification test results observed during the buffer stage dissolution testing.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 23, 2020. Severity: Moderate. Recall number: D-0148-2021.
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