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Recently, the State Food and Drug Administration organized an overseas off-site inspection of UCB Pharma SA in Belgium, and the inspected product was levetiracetam injection concentrated solution (Import Registration No.
: H20170341, specification 5 ml: 500 mg, trade name Kaipu orchid)
.
The inspection found that the validity period of some batches of products of this variety was inconsistent with the validity period of registration approval.
The inspection concluded that the production of this variety did not meet the requirements of China's "Good Manufacturing Practice for Drugs (Revised in 2010)"
.
In order to ensure the safety of public medication, in accordance with the relevant provisions of the Drug Administration Law of the People's Republic of China, the State Food and Drug Administration has decided to suspend the import, sale and use of this product in China from now on, and investigate and deal with relevant issues in accordance with the law
.
The drug supervision and administration departments of all import ports suspend the issuance of import customs clearance certificates for this product
.
Hereby announce
.
State Food and Drug Administration August 22, 2022
Recently, the State Food and Drug Administration organized an overseas off-site inspection of UCB Pharma SA in Belgium, and the inspected product was levetiracetam injection concentrated solution (Import Registration No.
