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Nationwide recall of Neurobion sugar coated tablets for the treatment of neurological disorders

On May 4, the Drug Administration of Vietnam, the Ministry of Health sent an official dispatch to the Departments of Health of the provinces and cities; Branch of Zuellig Pharma Vietnam Co., Ltd. on the notice of recall of drugs in violation of level 3.

According to this document, the Drug Administration of Vietnam announced a nationwide recall of the following drugs: Neurobion sugar coated tablets (Pyridoxin HCl (vitamin B6) 200mg; Vitamin B1 (Thiamine mononitrate) 100mg; Vitamin B12 (Cyanocobalamin) 200mcg), SDK: VN- 20021-16, Lot number: D0083217, NSX: 14.11.20, HD: 13.11.23 and Lot number: D0006203, NSX: 15.10.20, HD: 14.10.23 by PT. Merck Tbk (Indonesia) produced, branch of Zuellig Pharma Vietnam Co., Ltd. imported.

Nationwide recall of Neurobion sugar-coated tablets to treat neurological disorders of poor quality - Photo 1.

The Drug Administration of Vietnam has announced a nationwide recall of Neurobion sugar-coated tablets, which are indicated for the treatment of neurological disorders, imported by Zuellig Pharma Vietnam Co., Ltd.

The Drug Administration of Vietnam requires Zuellig Pharma Vietnam Co., Ltd. Branch to coordinate with drug suppliers and distributors, within 2 days from the date of signing this Official Letter, to send recall notices to wholesalers. , retail, use the above drugs and carry out the recall of the entire batch of drugs that do not meet quality standards; The company branch must send a recall report to the Drug Administration of Vietnam within 33 days from May 4.

The recall dossier includes the imported quantity, the date of importation, the quantity recalled, and evidences on the implementation of the recall at the wholesalers, retailers, and users who have purchased drugs as prescribed in this Circular. No. 11/2018/TT-BYT dated May 4, 2018 of the Ministry of Health regulating the quality of drugs and medicinal ingredients.

The Drug Administration of Vietnam also requested the Departments of Health of the provinces and cities directly under the Central Government, and the Health Departments to notify business and user establishments of recalling the batch of unqualified drugs, and to publish information on drug administration. decide on drug recall on the website of the Department, inspect and supervise the units implementing this notice; handle violators according to current regulations; report to the Drug Administration of Vietnam and relevant authorities.

City Department of Health. Ho Chi Minh City inspects and supervises the branch of Zuellig Pharma Vietnam Co., Ltd. to recall and handle the recalled drug according to regulations.

The decision of the Drug Administration of Vietnam was made based on Vietnam’s current regulations on drug management and based on test results of the HCM City Institute of Drug Testing showing that this drug does not meet quality standards. in terms of mass uniformity.

Neurobion sugar coated tablets are indicated in the treatment of: Nervous disorders and disorders where the three vitamins B1, B6 and B12 can affect. Includes diabetic polyneuropathy, post-inflammatory neuropathy, and alcoholic peripheral neuritis;

Neuritis and sciatic nerve pain; especially facial paralysis, low back pain, ankle syndrome, sciatica;

Disorders caused by vitamin B1, B6, B12 deficiency such as beriberi, iron-cell anemia, pyridoxine deficiency convulsions in children, peripheral neuritis.


According to Thai Binh

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