'Exercise caution': MHRA flags error on oxycodone packaging
The MHRA has urged pharmacists to “exercise caution” when dispensing specific batches of oxycodone hydrochloride oral solution after a “typographical error” was identified on the outer packaging.
The Medicines and Healthcare products Regulatory Agency (MHRA) issued a warning yesterday (November 29) after manufacturer Lucis Pharma Ltd informed the medicines watchdog of a “typographical error” on some batches of its oxycodone hydrochloride 10mg/ml oral solution packaging.
However, affected batches are not being recalled as there “is no risk to product quality and efficacy”, the medicines watchdog stressed.
Text on the rear side of the outer packaging incorrectly states “each 1ml of oxycodone hydrochloride oral solution contains 1mg of oxycodone hydrochloride”, the MHRA said.
The correct text should state “each 1ml of oxycodone hydrochloride oral solution contains 10mg of oxycodone hydrochloride”, it added.
The affected batch numbers are:
- 21050004
- 22080005
“Refer to the correct information”
Healthcare professionals “should exercise caution when dispensing or supplying this product”, the MHRA urged.
As the strength of the product is “printed correctly on all other sides of the outer packaging, including the label on the bottle”, professionals should refer to the correct information on the bottle label and the patient information leaflet inside the pack, the regulator added.
Patients do not need to take any action, as the medicine itself is not affected, the MHRA noted.