Ministry of Health recalls a batch of imported cancer treatment drugs

Vo Thu DNUM_BAZAFZCACE 16:41

A batch of Temozolomid Ribosepharm 100 mg medicine for treating certain types of brain cancer has just been requested to be recalled by the Drug Administration of the Ministry of Health due to level 3 violations.

On the morning of May 9, Deputy Director of the Department of Drug Administration Ta Manh Hung said that he had just signed an official dispatch announcing the nationwide recall of the drug batch Temozolomid Ribosepharm 100 mg, registration number VN2-626-17, Batch number: 2J6001, manufactured on August 17, 2022, expiry date August 31, 2025.

The product is manufactured by Haupt Pharma Amareg GmbH (Germany), imported by Nam Linh Pharmaceutical and Chemical Company Limited (located in Ho Chi Minh City).

Previously, during the inspection at Nam Linh Pharmaceutical and Chemical Company Limited, the Ministry of Health Inspection Team conducted a random inspection and discovered a batch of Temozolomid Ribosepharm 100 mg, Specification: box of 1 bottle of 5 hard capsules, without instructions for use in Vietnamese as prescribed.

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The Drug Administration of Vietnam (Ministry of Health) has requested the recall of the drug batch Temozolomid Ribosepharm 100 mg for the treatment of certain types of brain cancer, due to the lack of instructions for use in Vietnamese.

Temozolomide Ribosepharm 100mg is used to treat certain types of brain cancer. With the above actions, the Ministry of Health said the batch of drugs violated level 3.

The Drug Administration of Vietnam requires Nam Linh Pharmaceutical and Chemical Company Limited to coordinate with drug suppliers and distributors to send recall notices to wholesalers, retailers, and users of the above batch of drugs within 2 days (until May 10).

The local health departments and health departments of all sectors shall notify drug trading and using establishments to recall the above-mentioned batch of drugs; handle violators according to current regulations. The Ho Chi Minh City Department of Health shall inspect and supervise Nam Linh Pharmaceutical and Chemical Company Limited to recall and handle recalled drugs according to regulations./.

According to vietnamnet.vn
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Ministry of Health recalls a batch of imported cancer treatment drugs
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