Press release
| Date: | 13 September 2012 |
|---|---|
| Time: | 10:30 |
| Subject: | Diabetes patients urged to check Hypurin Porcine Isophane Insulin Cartridges after packaging error identified |
| Contact: | Press Office 020 3080 7651/ or press.office@mhra.gsi.gov.uk Out-of-hours 07770 446 189 |
The Medicines and Healthcare products Regulatory Agency (MHRA) is today urging those with diabetes using Hypurin Porcine Isophane insulin cartridges to check their medication after a packaging error came to light.
The issue occurred when a carton for cartridges of intermediate acting Hypurin Porcine Isophane Insulin 100 IU/ml got into the production line for the short acting Hypurin Porcine Neutral Insulin 100IU/ml. This could mean a patient experiences the insulin wearing off earlier than expected.
One such pack was identified by a pharmacist before it reached the patient and whilst the manufacturer, Wockhardt UK Ltd, believes it is highly unlikely there are any other such packs in the supply chain, patients and pharmacists are being asked to check their cartons.
The issue relates to one batch of Hypurin Porcine Neutral Insulin, with the batch number PL40147, and although it is considered highly unlikely that there are any other rogue packs in the supply chain, the MHRA has issued a drug alert following a precautionary recall by the manufacturer.
Pharmacists and wholesalers are being asked to check stocks of Hypurin Porcine Isophane Insulin and contact Wockhardt immediately if any packs of this insulin, embossed with this batch number, are identified.
Pharmacists are also asked to contact patients who may have stocks of this insulin. Cartons of Hypurin Porcine Neutral Insulin 100 IU/ml with the same lot number are not included in this recall and should not be returned. No other batches of Hypurin insulin are affected.
Gerald Heddell, MHRA Director of Inspection, Enforcement and Standards said: “It is important that patients continue to administer their insulin as required. Patients with any questions or concerns should contact their GP or pharmacist as soon as possible. An investigation has taken place and action has been taken to rectify the issue.”
Notes to Editor
1. The MHRA is the government agency responsible for ensuring that medicines and medical devices work, and are acceptably safe. No product is risk-free. Underpinning all our work lie robust and fact-based judgements to ensure that the benefits to patients and the public justify the risks. We keep watch over medicines and devices, and take any necessary action to protect the public promptly if there is a problem. We encourage everyone – the public and healthcare professionals as well as the industry – to tell us about any problems with a medicine or medical device, so that we can investigate and take any necessary action.
2. The drug alert can be viewed at:
Class 2 Drug Alert (Action within 48 hours): Hypurin Porcine Neutral Insulin 100 IU/ml Cartridges - Wockhardt UK Ltd - EL (12)A/29
