Class 2 Medicines Recall: Wockhardt UK Limited, WockAIR 160 microgram/4.5 microgram, inhalation powder, EL(24)A/62

Wockhardt UK Limited is recalling this batch 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.

DMRC Number: DMRC-34091841

Company name: Wockhardt UK Limited

Product description: WockAIR 160 microgram/4.5 microgram, inhalation powder, PL 29831/0736 SNOMED Code 40106011000001102

Details of the affected batch: 

Brief description of problem:

Wockhardt UK Limited is recalling the above batch 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.

Advice to Healthcare Professionals:

Stop supplying the above batch immediately. Quarantine all remaining stock and return it to your supplier using your supplier’s approved process.

Advice to Patients:

Wockhardt has advised MHRA that this is a rare defect and the pharmacy and wholesaler level recall is being undertaken as a precautionary measure. Patients should continue to take medicines from this batch as prescribed by your healthcare professional.

Patients should be aware that whilst a defect has been identified, it does not affect all inhalers within this batch. If a patient were to receive an inhaler with a defect, the defect would be obvious from the first attempted use of the product as the inhaler would not provide a dose.

Patients using an inhaler from this batch should continue to use the inhaler as the defect would not impact a working device. Patients that have an unopened inhaler from the batch in the table are advised to test the inhaler is working before their current inhaler runs out.

The batch number can be found at the bottom of the label on the back of the device. If patients find that their inhaler is affected by this defect, they should return it to their pharmacist who can advise on the provision of an alternative inhaler.

Patients who experience adverse reactions or have any questions about the medication, should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme.

Company contacts for further information:

For medical information enquiries please telephone 01978 661261 and ask for ‘drug safety’, or email drug.safety@wockhardt.co.uk.

For stock control enquiries please telephone 01978 661261 and ask for ‘customer services’, or email group_uk_csu@wockhardt.co.uk.

To access the full recall: Class 2 Medicines Recall: Wockhardt UK Limited, WockAIR 160 microgram/4.5 microgram, inhalation powder, EL(24)A/62