Biemefrin 4mg/4ml IV Infusion Solution Containing 10 Ampoules which is found to be inappropriate as a result of the examination, a recall process has been applied

Purpose:

The Turkish Ministry of Health has announced the recall of a specific medicinal product, “Biemefrin 4mg/4ml IV Injection Solution for Infusion Containing 10 Ampoules,” due to unsatisfactory results from an inspection and analysis conducted on January 28, 2025. This action is based on the “Regulation on the Withdrawal of Human Medical Products and Special Dietary Foods” published in the Official Gazette dated October 23, 2024.

Effects on Industry:

The recall of this medicinal product may have immediate effects on Biem İlaç San. ve Tic. A.Ş., the company responsible for manufacturing and distributing the product. The company must comply with the regulations outlined in the relevant law, which includes implementing a Class B-level (first-tier user level) withdrawal process. This means that all places supplying the product directly to end-users must take necessary steps to ensure its safe removal from circulation.

The recall may also have long-term effects on the pharmaceutical industry as a whole, potentially influencing consumer trust and confidence in medicinal products. Biem İlaç San. ve Tic. A.Ş.’s reputation may be impacted if not handled properly, affecting future sales and business relationships.

Relevant Stakeholders:

This update directly affects the following stakeholders:

• Biem İlaç San. ve Tic. A.Ş., as they must comply with the regulations outlined in the relevant law.
• Healthcare professionals, as they need to be informed about the recall of the medicinal product and its safe removal from circulation.
• Consumers, who may have been affected by the use or possession of the recalled product.

Next Steps:

Biem İlaç San. ve Tic. A.Ş. must take immediate action to ensure compliance with the regulations outlined in the relevant law. This includes:

1. Implementing a Class B-level withdrawal process for all places supplying the product directly to end-users.
2. Informing healthcare professionals and consumers about the recall of the medicinal product and its safe removal from circulation.

Any Other Relevant Information:

The Turkish Ministry of Health has announced this recall as part of ongoing efforts to ensure public safety and protect consumer health. The relevant law and regulations provide a framework for companies to follow in such situations, ensuring that they are held accountable for their actions.