A small number of glass bottles from some batches of Briviact® 10mg/mL oral solution, 300 mL, have a slightly narrower neck diameter, making it difficult to insert the press-in bottle adapter (PIBA) to extract the solution with the oral syringe.

• Discuss this issue with the patient/caregiver when dispensing the product and, if possible, check with the patient/caregiver if the PIBA fits in the dispensed bottle. If the PIBA does not fit in the dispensed bottle and there are difficulties extracting the dose, a replacement bottle should be provided.
• The issue of narrow neck of the bottle does not impact the safety of the Briviact® oral solution itself. However, a minimal risk of dosing error due to the use of the defective bottle or to the use of the syringe without the PIBA, cannot be ruled out.
• UCB is working with glass bottle manufacturer to solve this issue. The potentially impacted batch numbers are provided below and per your country one or more of the batches may be applicable. There may be very few bottles affected in the distributed batches whose shelf-life is up to 2025. Therefore, complaints could be received until that timeline.

Potentially impacted batches include batch number 296954, 299727, 299736, 299738, 299914, 300505, 301008, 301010, 301918, 302346, 302874, 302960, 302961, 303261, 304171, 304173, 304224, 305150, 305151, 305657, 305708, 306231, 306232, 306233, 306234, 306235, 306236, and 308284;  of which only the batch 299727 was distributed in Italy.