Class III
Terminated
Tecfidera (dimethyl fumarate) delayed-release capsules, 240 mg, 60-count bottle, Rx only, Manufactured by: Biogen Inc., Cambridge, MA 02142, NDC 64406-006-02
- Company
- Biogen Ma Inc.
- Recall Initiated
- June 23, 2020
- Posted
- July 15, 2020
- Recall Number
- D-1381-2020
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 3,922 bottles
- Firm Location
- Research Triangle Park, NC, United States
Reason for Recall
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.
Lot / Code Info
Lot # SH0274, Exp 2/2022
More recalls by Biogen Ma Inc.
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