Parents of young children should check the lot numbers of their Doliprane 2.4% oral suspension, a common over-the-counter medication for fever and pain, after a recall was announced on . The recall, issued by the French National Agency for the Safety of Medicines and Health Products (ANSM), stems from a manufacturing defect affecting the graduated pipettes used to measure the liquid medication.
According to the ANSM, the markings on the pipettes can fade gradually after being rinsed with warm or hot water. This poses a potential risk of accidental overdose, particularly in infants and young children, if parents are unable to accurately measure the correct dosage. While the medication itself remains safe and effective, the inaccurate measurement could lead to administering too much paracetamol.
Affected Lots and How to Identify Them
The recall affects 27 lots of Doliprane 2.4% oral suspension manufactured between and . The affected lot numbers are:
- Expiration date 08/2027: L033, L034, L035, L036
- Expiration date 09/2027: L037, L038, L039, L040, L041, L042, L043, L044, L045, L046, L047, L048, L049
- Expiration date 10/2027: L050, L051, L053, L054, L055, L056, L057, L058, L061, L062
Parents can find the lot number on the outer packaging, typically located on the back within a white box alongside the expiration date, and also on the label directly affixed to the bottle.
What to Do If You Have an Affected Product
The ANSM advises consumers who have any of the affected products to return them to their pharmacy for a free replacement. The manufacturer, Opella Healthcare France, has assured that sufficient stock is available to prevent any disruption in supply.
The Importance of Accurate Medication Dosage
This recall highlights the critical importance of accurate medication dosage, especially in pediatric populations. Even small errors in dosage can have significant consequences for infants and young children. The use of appropriate measuring tools is paramount.
Research has demonstrated that the use of household spoons or imprecise measuring devices can lead to significant dosing errors. A 2016 study published in Pediatrics found that dosing cups greatly increased the risk of errors, particularly with smaller dose amounts. The study emphasized the need for clear markings and standardized dosing tools.
The issue with the Doliprane pipettes specifically concerns the fading of the graduation markings. So that a parent attempting to measure a precise dose may inadvertently administer too little or, more concerningly, too much medication. The ANSM specifically noted the risk of a potential overdose of paracetamol.
What Caused the Problem?
The manufacturing issue was traced to a production facility operated by Opella Healthcare France. The company has stated that the problem has since been corrected, and measures have been taken to ensure that future batches of Doliprane do not exhibit this defect. The issue is isolated to the pipette itself. the quality and integrity of the paracetamol syrup within the bottle remain unaffected.
A press release from May 15th clarified that the defect is limited to the pipette’s graduation markings, and does not affect the syrup itself. The agency has not received any reports of adverse events linked to this printing defect to date, suggesting the recall is a preventative measure.
Preventative Measures and Ongoing Monitoring
While no adverse events have been reported in France, the ANSM’s proactive recall demonstrates a commitment to patient safety. Pharmacists are now advised to check the condition of the pipette when dispensing the affected batches to ensure accurate dosing.
Parents should always carefully read the instructions on medication packaging and consult with a healthcare professional if they have any questions or concerns about administering medication to their children. Accurate measurement is crucial, and if there is any doubt about the integrity of the pipette, it should be returned to the pharmacy for a replacement.
