D-1381-2020 Class III Terminated
FDA drug recall D-1381-2020 was initiated by Biogen MA Inc. on June 23, 2020 and is designated Class III. Reason for recall: cGMP deviations: one lot of the product was distributed to US Markets despite being rejected during in-process control. The recall status is terminated (terminated February 11, 2021). Affected quantity: 3,922 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- July 15, 2020
- Initiation Date
- June 23, 2020
- Termination Date
- February 11, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,922 bottles
Product Description
Tecfidera (dimethyl fumarate) delayed-release capsules, 240 mg, 60-count bottle, Rx only, Manufactured by: Biogen Inc., Cambridge, MA 02142, NDC 64406-006-02
Reason for Recall
cGMP deviations: one lot of the product was distributed to US Markets despite being rejected during in-process control.
Distribution Pattern
Product was distributed to wholesalers/distributors in KY, OH & MS.
Code Information
Lot # SH0274, Exp 2/2022