The Spanish Agency for Medicines and Health Products (AEMPS), which operates under the Ministry of Health, currently led by Carolina Darias, has identified multiple health concerns within Spain in less than a month.
The public body has issued orders to remove certain widely used drugs and health products from the market due to potential risks to people's health.
Withdrawal of a medical gas used in hospitals
The first notice from the AEMPS was issued on May 19 and pertained to a medical gas intended for hospital use. Specifically, it involved 530 batches of Medical Oxygen Gas Metal Carbides 99.5% V/V Compressed gas, 1 gas bullet of 5 litres, manufactured by the Spanish Society of Metal Carbides. The withdrawal was prompted by a "quality defect that may potentially affect the integrity of containers" meant for hospital use.
This medication, delivered in the form of compressed oxygen, is administered to hospitalised patients to enhance blood oxygenation levels in cases of hypoxia. Consequently, it facilitates improved oxygen transport to all body tissues, ensuring proper blood pressure and tissue perfusion.
Hydrogen peroxide sold in stores and supermarkets
Merely a week later, the AEMPS issued another alert, this time concerning an alcohol-based product intended for household use that is popularly available in pharmacies. The alert was prompted by a "labelling error" associated with Optisana Alcohol 96º with antiseptic benzalkonium chloride for healthy skin, manufactured by Laboratorios Montplet in Barcelona.
These biocidal products are distributed to the general public through common commercial channels such as supermarkets and convenience stores.
Upon receiving a notification, it was discovered that the product did not comply with regulations due to incorrect labelling. The authorities have urged individuals who possess a unit of the product with batch number 30362 to refrain from using it and return it to the point of purchase. Although the effects on the skin are similar, the confusion could lead to incompatibilities in patient treatment.
Reflux and heartburn drug
On June 7, just two days later, a new health alert was issued concerning RefluAliv, a drug used for the treatment and prevention of gastroesophageal reflux, gastric hyperacidity, and the protection of the stomach and esophageal mucosa. Manufactured by Labomar and distributed in Spain by Cinfa, the withdrawn batch is numbered 1989 M as it failed to meet the required microbiological conditions.
After receiving a consumer complaint regarding an "organoleptic non-conformity," the AEMPS took action. According to the statement released by the agency, an investigation conducted on the products revealed microbiological deviations from the specified standards.
The report clarifies that no pathogenic microorganisms posing a health risk have been identified. However, the issue detected has the potential to cause organoleptic changes in the product, such as alterations in colour, smell, flavour, and so on.
The AEMPS has urgently requested pharmacies and distributors of the product thoroughly examine their inventory to determine whether they have units of the medicine from the affected batch, identified as L1989M.
Furthermore, patients have been advised to verify if they possess the specific product in question. The lot number can be found on the side of the packaging as well as on each individual sachet.
If individuals possess the affected batch, they are instructed to discontinue its use and contact the establishment where the product was purchased in order to return it.
Additionally, if any lack of efficacy or organoleptic changes, such as alterations in taste and texture, are noticed, patients are advised to inform the pharmacy at the time of returning the product.
September 20, 2023