Pulmicort 0.25mg/ml nebuliser suspension, AstraZeneca Pty Ltd, CON-1230

• the product specification does not include all the tests required by the British Pharmacopoeia (BP) monograph; • the test method for related substances with regard to mobile phase, system suitability and limits were not carried out and instead replaced by an in-house validated test; and • the assay specified as mg/ml in the product specification to determine the amount of active available in the product at shelf life stage is outside the range specified in the BP monograph of 92.5% to 105.0% of the stated amount.