June 2020 FDA Recall Tecfidera by Biogen Ma Inc.
D-1381-2020 - cGMP deviations
This Class III drug recall was voluntarily initiated by Biogen Ma Inc. on June 23, 2020 for the product Tecfidera. The FDA reported the reason for recall as cgmp deviations. The product was distributed in Product was distributed to wholesalers/distributors in KY, OH & MS. and the recall is currently terminated.
Recall Number: D-1381-2020
cGMP deviations: one lot of the product was distributed to US Markets despite being rejected during in-process control.
06-23-2020
07-15-2020
3,922 bottles
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Biogen MA Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Product was distributed to wholesalers/distributors in KY, OH & MS.
02-11-2021
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Tecfidera (dimethyl fumarate) delayed-release capsules, 240 mg, 60-count bottle, Rx only, Manufactured by: Biogen Inc., Cambridge, MA 02142, NDC 64406-006-02
Batch or Lot Expiration Information
Lot# SH0274, Exp 2/2022
