France’s national agency for the safety of medicines and health products (ANSM) on Monday announced a recall of certain batches of Doliprane 2.4% oral suspension for children, citing a defect that could lead to dosage errors. The recall stems from the potential for the graduation markings on the dropper bottles to become erased if rinsed with warm or hot water.
According to the ANSM, the loss of these markings could result in parents or caregivers administering an incorrect dose of paracetamol, potentially leading to an overdose in infants and young children weighing between 3 and 26 kilograms. The agency emphasized that the quality of the medicine itself is not compromised.
The laboratory Opella Healthcare France, in agreement with the ANSM, is initiating the recall of 27 batches of the product that utilize the affected dropper bottles. Consumers who possess a box from one of the recalled batches are instructed to return it to their pharmacy for a free replacement. The batch number can be found on the packaging, typically on the back of the box or on the label affixed to the bottle.
The ANSM directed individuals to its website to determine if their medication is affected. The agency provided instructions on locating the batch number on the product packaging, noting that its location may vary depending on the specific box design.
The recall comes amid broader concerns about drug shortages in Europe, as reported by Le Monde. While not directly linked to the Doliprane recall, the wider issue highlights vulnerabilities in pharmaceutical supply chains. A recent report by Le Monde detailed the complex factors contributing to these shortages, including production issues and global demand.
Separately, a recent French study indicated that expired medication retains a significant degree of effectiveness, with approximately 90% efficacy even after the stated expiration date, according to The Connexion. This finding, while not related to the current recall, adds another layer to the ongoing discussion surrounding medication safety and access in France.
Concerns over potential medicine shortages in France were previously raised due to the Covid-19 outbreak in China, as reported by Le Monde. The potential disruption to the supply of active pharmaceutical ingredients from China prompted fears of limited availability of certain medications in France, though this did not directly cause the Doliprane recall.
The ANSM has not yet indicated when the recalled batches will be replaced or if the design of the dropper bottles will be modified to prevent future occurrences of the issue.
