Other safety alerts
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| Updates on Pulmicort Turbuhaler 200 µg per metered dose (200doses) (HK-33965) |
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Subsequently to the Department of Health’s press release on 27 July 2012, the certificate holder of the above product, AstraZeneca Hong Kong Ltd (AstraZeneca) provided their assessment report on the incident related to the potential malfunction of the delivery device of the product.
AstraZeneca confirmed that the issue only affects Pulmicort Turbuhaler 200µg per metered dose (200 doses) (HK-33965). AstraZeneca informed that the investigation of the complaints showed that there was a partially broken/damaged tooth in the dosing unit of the complaint samples. The investigation determined that the cavity mould for Pulmicort 200 µg dosing units do not comply with measurements specified in the tool drawings. This has affected the strength of the teeth.
Base on risk assessment, DH dictated AstraZeneca to quarantine the remaining stock of Pulmicort Turbuhaler 200µg per metered dose (200 doses) (HK-33965) and allowed to distribute the product unless with good quality delivery device.
Ends/ Thursday, August 02, 2012
Issued at HKT 20:00 |
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