Tecfidera recall: CGMP Deviations
Tecfidera (dimethyl fumarate) delayed-release capsules, 240 mg, 60-count bottle, Rx only, Manufactured by: Biogen Inc., Cambridge, MA 02142, NDC…
Why was Tecfidera recalled?
cGMP deviations: one lot of the product was distributed to US Markets despite being rejected during in-process control.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot # SH0274, Exp 2/2022
- Product
- Tecfidera (dimethyl fumarate) delayed-release capsules, 240 mg, 60-count bottle, Rx only, Manufactured by: Biogen Inc., Cambridge, MA 02142, NDC…
- Recalling firm
- Biogen MA Inc.
- Quantity
- 3,922 bottles
- Distribution
- Product was distributed to wholesalers/distributors in KY, OH & MS.
- Recall date
- July 15, 2020
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)