DOLIPRANE 2.4% drinkable: alert concerning pipettes without graduation

DPipettes without graduations were discovered in 7 batches of DOLIPRANE 2.4% oral suspension (paracetamol – see. Drawing):

  • batch 3KLR12D1;
  • batch 3KLR13D2;
  • lot 3KLQ70DU;
  • lot 3KLQ69DT;
  • lot 3KLR14D3;
  • lot 3KLQ71DV;
  • lot 3KLQ72DW.

Illustration – Pipette without graduation (defective) versus pipette with graduation (compliant)

According to information communicated by the Opella Healthcare France laboratory [1]these batches have a total of more than 1.3 million boxes, but the graduation defect was only identified on around thirty pipettes.

The defect only concerns the pipette (see. Boxed). The integrity and quality of the medicine contained in the bottle are intact.
No pharmacovigilance cases related to this printing defect have been reported to date.

Box – A pipette graduated in kg to administer the right dose of paracetamol

DOLIPRANE 2.4% is indicated for the symptomatic treatment of mild to moderate pain and/or febrile conditions in children.

Each box of DOLIPRANE 2.4% oral suspension contains a 100 mL bottle and a weight pipette graduated in kg (from 3 to 26 kg). This device makes it possible to administer the dose of paracetamol corresponding to the weight of the infant or child (15 mg of paracetamol in increments of 1 kg).

No reminder, but instructions: check and, if necessary, exchange

“The manufacturer of the pipettes claims to have taken measures to ensure that new batches do not contain this defect”, underlines the National Agency for the Safety of Medicines and Health Products (ANSM). Pending this compliance, boxes of DOLIPRANE 2.4% belonging to the batches concerned can be delivered to pharmacies subject to applying the following precautions:

  • identify the boxes of batches 3KLR12D1, 3KLR13D2, 3KLQ70DU, 3KLQ69DT, 3KLR14D3, 3KLQ71DV, 3KLQ72DW held in the pharmacy stock;
  • check each box for the presence of the graduation on the pipette at the time of delivery;
  • If non-compliant pipettes are found, contact the Opella laboratory on 0 801 907 577 to return the product and obtain a credit note.

Instructions are also given to patients who may have this medication:

  • check that the pipette supplied with the bottle is correctly graduated;
  • if a pipette without a graduation is found, do not use it and do not use the pipette from another medication either (risk of underdosing and/or overdose);
  • return the box containing the non-graduated pipette to the pharmacy for exchange.
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