Medicine recalls
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| The United Kingdom: Class 2 Medicines Recall: Wockhardt UK Limited, WockAIR 160 microgram/4.5 microgram, inhalation powder |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that Wockhardt UK Limited is recalling one batch of WockAIR 160 microgram/4.5 microgram, inhalation powder (budesonide/formoterol fumarate dihydrate) (batch number: NV6057) as a precautionary measure following the identification of a low number of units which may have a defect in the ‘top case’ resulting in a dose not being able to be dispensed.
The product is indicated in adults and adolescents (12 years and older) for the regular treatment of asthma where use of a combination (inhaled corticosteroid and long-acting β2 adrenoceptor agonist) is appropriate, and as reliever therapy for mild asthma. It is also indicated in adults, aged 18 years and older, for the symptomatic treatment of patients with chronic obstructive pulmonary disease (COPD) with forced expiratory volume in 1 second (FEV1) <70% predicted normal (post bronchodilator) and an exacerbation history despite regular bronchodilator therapy.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/class-2-medicines-recall-wockhardt-uk-limited-wockair-160-microgram-slash-4-dot-5-microgram-inhalation-powder-el-24-a-slash-62
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Tuesday, Dec 10, 2024
Issued at HKT 15:00
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