DH notified of batch recall of NovoPen Echo and NovoPen 5
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Novo Nordisk reported that the insulin cartridge holder in some batches of the above two devices might crack or break if exposed to certain chemicals such as cleaning agents. Diabetes patients receiving insulin treatment with such devices should replace the cartridge holder. The affected batches are:
| Device | Affected batches in Hong Kong |
|---|---|
| NovoPen Echo | EVG6823-6, FVG8413-6 |
| NovoPen 5 | DVG1930-1, EVG1027-2, EVG1125-2, EVG2296-1, FVG8655-2, FVG8656-1, FVG8659-3, FVG8888-1 |
Initial enquiries of the manufacturer revealed that the new plastic material used in the cartridge holder in the affected batches could be weakened if exposed to certain chemicals. As a precautionary measure, the manufacturer has changed the material of the cartridge holder.
"A cracked or broken cartridge holder can deliver a smaller than intended dose of insulin to diabetes patients and may lead to high blood sugar. If symptoms develop, such as excessive thirst, frequent urination, fatigue, dehydration, fruity odour to the breath or loss of appetite, patients should seek medical advice immediately," a spokesman for the DH said.
According to the local supplier, 74 units of NovoPen Echo and over 8 000 units of NovoPen 5 of the affected batches have been distributed to the local market. Apart from recall from wholesalers, pharmacies, hospitals and doctors, patients using the affected devices should register online (www.novonordisk.com.hk or www.novonordisk.com) or contact the customer service of the local supplier to collect an unaffected cartridge holder. It has set up a hotline (2387 8555) and email address (HK-enquiry@novonordisk.com) for customer enquiries and adverse events.
"We will alert public and private hospitals as well as relevant medical associations to the recall and replacement notice, and will liaise with the local supplier on the follow-up actions. No adverse events in connection with the devices have been received so far," the spokesman added.
"Members of the public should consult healthcare professionals if in doubt or feeling unwell after using their medical devices," the spokesman said.
Ends/Monday, July 3, 2017
Issued at HKT 19:38
Issued at HKT 19:38
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