Tecfidera (dimethyl fumarate)
cGMP deviations: one lot of the product was distributed to US Markets despite being rejected during in-process control.
National Drug Code
Tecfidera · 1 BOTTLE, PLASTIC in 1 CARTON (64406-006-02) / 60 CAPSULE in 1 BOTTLE, PLASTIC
2 FDA recalls name the code 64406-0006-02 directly. A recall still applies to particular lot numbers — compare the lot on your package with the FDA notice below, and talk to your pharmacist before stopping a prescribed medication.
cGMP deviations: one lot of the product was distributed to US Markets despite being rejected during in-process control.
Lack of Processing Controls.
Where to find this code. The NDC is printed on the pharmacy label and on the manufacturer's carton, usually as three groups of digits after “NDC”. The last group is the package size — two bottles of the same medicine can differ only in that group, and a recall may cover one but not the other.
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