The cControl of all medical and pharmaceutical products that are marketed throughout the national territory is a matter of vital importance for the Ministry of Health and Consumption. This portfolio maintains close surveillance through the Spanish Agency for Medicines and Health Products, which is “responsible for guaranteeing society, from a public service perspective, the cquality, safety, efficacy and correct information on medicines and health products, from its research to its use, in the interest of protecting and promoting human health, animal health and the environment” This agency is dedicated, among other things, to “continuous monitoring of the safety and efficacy of medicines once they are marketed and the control of their quality” and “monitoring of the safety of cosmetics and personal care products”
Now, Aemps has issued a drug alert for human use through its digital portal to report that has found irregularities in the drug Tromboben 1 mg/g.- It is, according to the agency itself, a a cream “for cutaneous use that applied to the skin improves blood flow” and is used for “local symptomatic relief of superficial venous disorders such as heaviness and tightness in legs with varicose veins in adults” and “local symptomatic relief of superficial bruising caused by blows in adults and children over 1 year of age”
The Spanish Agency for Medicines and Health Products explains that the defect is due to the “detection of an out of specification in the amount of active principle”. PFor this reason, Aemps has decided to adopt as a precautionary measure the “withdrawal from the market of all distributed units of batch N03 and return to the laboratory through the usual channels”. At the same time, has asked the health agencies of the different autonomous communities follow up on the withdrawal.
The Ministry of Health also maintains tight control over those food products that may pose a risk to the user