Recall of substandard batch of anti-inflammatory Alfachim 4.2

The Drug Administration of Vietnam (Ministry of Health) said that the unit has just signed and issued a decision to recall nationwide Alfachim 4.2 Tablets (Chymotrypsin (equivalent to 21 microkatal chymotrypsin) 4200 IU), Registration Certificate No. VD-34573-20, Batch No. 03010624; Production date June 1, 2024; Expiry date June 1, 2026. The product is manufactured by Cuu Long Pharmaceutical Joint Stock Company.

This is an anti-edema and anti-inflammatory drug; used in the treatment of edema after trauma, burns, and surgery.

In May, the Central Institute for Drug Control sent a report to the Drug Administration of Vietnam that the above drug sample did not meet the quality standards for quantitative indicators (level 2 violation). At that time, the Drug Administration of Vietnam requested to recall this batch of drugs in Hanoi .

At the same time, the Department requested Cuu Long Pharmaceutical Joint Stock Company to coordinate in taking 2 additional samples and send the collected samples to the Central Drug Testing Institute or the Ho Chi Minh City Drug Testing Institute (an agency under the Ministry of Health ) to check the quality of quantitative indicators.

However, even though the required 15-day deadline has passed, Cuu Long Pharmaceutical Joint Stock Company has not yet reported to the Drug Administration the results of the quality inspection of the two additional samples. The company only reported on the production, distribution of the drug and the recall report.

Cuu Long Pharmaceutical Joint Stock Company has sent a document to the Department of Drug Administration, requesting a voluntary recall of the batch of Alfachim 4.2 Tablets.

In the latest dispatch, the Drug Administration requested Cuu Long Pharmaceutical Joint Stock Company to coordinate with drug distributors to promptly send recall notices to wholesalers and retailers using the batch of Alfachim 4.2 Tablets (Chymotrypsin (equivalent to 21 microkatal chymotrypsin) 4200 IU), to recall the entire batch of drugs that do not meet the above quality standards.

The Hanoi City Department of Health and the Vinh Long Province Department of Health are required to inspect and supervise Cuu Long Pharmaceutical Joint Stock Company to recall and handle recalled drugs according to regulations.

The Department also requested these two departments to evaluate the effectiveness of the drug recall, such as whether the recall was thorough, whether the product is still likely to continue to be circulated and used, and whether it poses a risk of adversely affecting the health of users.

HAI NGO

Source: https://nhandan.vn/thu-hoi-lo-khang-viem-alfachim-42-khong-dat-chat-luong-post888727.html