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 reference number
DMRC-34091841
Company name
Wockhardt UK Limited
WockAIR 160 microgram/4.5 microgram, inhalation powder, PL 29831/0736
SNOMED Code
40106011000001102
| Batch Number | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| NV6057 | 30 April 2026 | 2 pack inhaler | 01 October 2024 |
Active Pharmaceutical Ingredient: budesonide/formoterol fumarate dihydrate
Brief description of the 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 for 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 for 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.
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.
Recipients of this Medicines Recall should bring it to the attention of relevant contacts by copy of this notice. NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information.
Yours faithfully
Defective Medicines Report Centre
10 South Colonnade
Canary Wharf
London
E14 4PU
Telephone +44 (0)20 3080 6574
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