Class 4 Medicines Defect Information: Lucis Pharma Ltd, Oxycodone Hydrochloride 10mg/ml oral solution, EL (22)A/49

Lucis Pharma Ltd has informed the MHRA that there is a typographical error with text on the rear side of the outer packaging for Oxycodone Hydrochloride 10mg/ml Oral Solution.

MDR Number: MDR 176-11/22

Company name: Lucis Pharma Ltd

Product description: Oxycodone Hydrochloride 10mg/ml oral solution, PL 42176/0015

Details of the affected batch:

Brief description of problem:

Lucis Pharma Ltd has informed the MHRA that there is a typographical error with text on the rear side of the outer packaging for Oxycodone Hydrochloride 10mg/ml Oral Solution.

The text incorrectly states that: ‘Each 1ml of oxycodone hydrochloride oral solution contains 1mg of oxycodone hydrochloride.’

The correct text should state: ‘Each 1ml of oxycodone hydrochloride oral solution contains 10mg of oxycodone hydrochloride.’

The strength of the product is printed correctly on all other sides of the outer packaging, including the label on the bottle.

Advice to Healthcare Professionals:

Healthcare professionals should note that there is no risk to product quality and efficacy, therefore the affected batches are not being recalled.

Healthcare professionals should exercise caution when dispensing or supplying this product. Please refer to the correct information stated on the bottle label and in the Patient Information Leaflet inserted in the pack.

Advice to Patients:

This notification relates to a typographical error on the outer packaging of the product. The medicine itself is not affected and patients do not need to take any action.

Company contacts for further information:

For medical information and stock control queries please contact: enquiries@lucispharma.co.uk.

To access the full recall: Class 4 Medicines Defect Information: Lucis Pharma Ltd, Oxycodone Hydrochloride 10mg/ml oral solution, EL (22)A/49