• Wed. Jun 12th, 2024

Imported cancer drugs recalled for not featuring Vietnamese instructions

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May 10, 2024

The Drug Administration of Vietnam, under the Ministry of Health, has issued a recall for a batch of Temozolomid Ribosepharm 100 mg, used in the treatment of certain types of brain cancer. The recall was initiated because the batch did not include instructions for use in Vietnamese. The specific information for the batch includes circulation registration number VN2-626-17, batch number 2J6001, manufacture date of August 17, 2022, and an expiry date of August 31, 2025. The drug is manufactured by Haupt Pharma Amareg GmbH in Germany and imported by Nam Linh Pharmaceutical and Chemical Company Limited in Ho Chi Minh City. This particular medication was imported from Germany and is intended for the treatment of brain cancer. As a result of the missing user manual in Vietnamese, the drug has been recalled nationwide.

On May 9, the Deputy Director of the Drug Administration, Ta Manh Hung, announced the recall decision following an inspection of Nam Linh company by the Ministry of Health. It was discovered that the batch of Temozolomid Ribosepharm 100 mg did not have the necessary user manual in Vietnamese, leading to the recall. According to regulations on drug management in Vietnam, imported drugs must have mandatory content in Vietnamese on the original label or provide a Vietnamese secondary label and instructions for use in Vietnamese. Failure to comply with these regulations results in a violation at level 3.

Apart from the drug recall announcement, the content also includes unrelated information about protecting personal information, dealing with negative feedback on products, writing a resume for a career in interior design, promoting diversity in law school, and other topics. These additional topics do not relate to the drug recall issue.

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