Research Triangle Park, NC, United States
Biogen MA Inc. recalls
2 recalls recorded since 2018, most recently on 9 December 2020. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)0
Terminated or completed2
Class I (FDA)0
Terminated Class II Drugs
- Recall started
- 9 December 2020
- Terminated
- 17 September 2021
- Reason
- Failed dissolution specifications: out-of-specification test results observed during the buffer stage dissolution testing.
- Distribution
- USA Nationwide
- Initiated
- Voluntary: Firm initiated
- 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
Terminated Class III Drugs
- Recall started
- 23 June 2020
- Terminated
- 11 February 2021
- Reason
- cGMP deviations: one lot of the product was distributed to US Markets despite being rejected during in-process control.
- Distribution
- Product was distributed to wholesalers/distributors in KY, OH & MS.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1381-2020
- Tecfidera (dimethyl fumarate) delayed-release capsules, 240 mg, 60-count bottle, Rx only, Manufactured by: Biogen Inc., Cambridge, MA 02142, NDC 64406-006-02
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.