The Ministry of Health recalls a batch of imported cancer treatment drugs.
A batch of Temozolomid Ribosepharm 100 mg, a medication used to treat certain types of brain cancer, has been ordered to be recalled by the Drug Administration of the Ministry of Health due to a level 3 violation.
On the morning of May 9th, Deputy Director of the Drug Administration Department, Ta Manh Hung, announced the nationwide recall of 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) and imported by Nam Linh Pharmaceutical and Chemical Company Limited (located in Ho Chi Minh City).
Previously, during an inspection at Nam Linh Pharmaceutical and Chemical Company Limited, the Ministry of Health's inspection team conducted a random check and discovered that one batch of Temozolomid Ribosepharm 100 mg tablets (Packaging: 1 bottle of 5 hard capsules) lacked the required instruction leaflet in Vietnamese.
Temozolomide Ribosepharm 100mg is used to treat certain types of brain cancer. Based on the aforementioned violations, the Ministry of Health agency stated that the batch of medicine violated regulations at level 3.
The Drug Administration Department requires Nam Linh Pharmaceutical and Chemical Company Limited to coordinate with its suppliers and distributors to send recall notices to all wholesalers, retailers, and users of the aforementioned batch of medicine within two days (by May 10th).
Local health departments and health agencies are notifying businesses and users of the recalled batch of drugs that violated regulations; and handling violations according to current regulations. The Ho Chi Minh City Department of Health is specifically tasked with inspecting and supervising Nam Linh Pharmaceutical and Chemical Company Limited in carrying out the recall and handling of the recalled drugs in accordance with regulations.
