Batches of three drugs for Parkinson’s, epilepsy and blood clots are recalled over fears they were stored wrongly and could be ‘seriously ineffective’
- The Medicines and Healthcare products Regulatory Agency gave the warning
- Certain batches of B&S Healthcare Clexane, Neupro and Vimpat are affected
- If patients have the exact batch numbers listed below they should contact a GP
Medicines for patients with Parkinson’s, epilepsy and blood clots are being recalled over fears they were wrongly stored and could be ‘seriously’ ineffective.
People with packs of Clexane, Neupro or Vimpat with a B&S Healthcare logo may be affected by the recall.
The manufacturer, B&S Healthcare, has warned the drugs were temporarily taken out of the supply chain so may not have been stored properly.
As a result, they may be less effective than they should be and health watchdogs have now asked pharmacists to return them.
Other medicines for chronic obstructive pulmonary disease, psoriasis and high cholesterol have also been recalled from pharmacists, not patients.
The Medicines and Healthcare products Regulatory Agency (MHRA) said it’s very unlikely that any patients will suffer but the effects ‘could be serious’.
The body, which polices the safety of medicine, said no patients should stop taking their medication without being told to do so by a GP.
The UK’s Medicines and Healthcare products Regulatory Agency has recalled batches of three types of medicines used to treat Parkinson’s, epilepsy and blood clots (stock image)
‘For three particular medicines, whilst the likelihood of their effectiveness being compromised is low (because they are stable legitimate medicines), the consequences of a lack of effectiveness could be serious which is why we are treating them differently,’ the MHRA said.
‘If patients have any of these affected products… they should continue taking their medicines and contact their GP practice to arrange a new prescription.
‘Once they have a new prescription, patients should return the affected batches to their pharmacist.’
HOW CAN HIGH OR LOW TEMPERATURES STOP DRUGS WORKING?
Medicines usually come with storage instructions which dictate whether, for example, they should be stored in a fridge or at room temperature.
How medicines are stored is crucial for making sure they stay effective in the period before a patient needs to take them.
Many medicines need to be kept between 2°C and 8°C – fridge temperature, while some need to be below 15°C or below 25°C – room temperature.
If drugs are not kept within their safe storage limits, the chemicals inside them may be damaged.
Extremes of cold or heat can irreversibly damage the shape of proteins which are needed for the drugs to work. For antibiotics, for example, if the chemical structure of a drug changes it could lose its ability to attach to the bacteria or viruses it is designed to fight.
Temperatures may also cause physical changes to medicines which aren’t completely solid.
Mixed emulsions, suspensions or suppositories may separate or settle in certain temperatures, while components in liquid medicines may crystallise if they get to cold.
And some drugs contain chemicals which only dissolve in liquid at certain temperatures, so if they get too hot or cold they can become unstable.
Source: Medicines Control Agency
Clexane is an injectable drug which stops the blood from clotting in patients with deep vein thrombosis (DVT), pregnant women or after a heart attack.
Neupro patches stick to the skin and release a drug called rotigotine to treat the symptoms of Parkinson’s disease.
And Vimpat, which comes in tablets, is an anti-seizure medication given to patients over the age of four who have epilepsy.
All the medicines affected by the recall are in Italian packaging and have a British B&S Healthcare label on them.
They have expiry dates between June 30, 2019, and June 30, 2023 and a total of 69 batches are subject to the warning.
Others which pharmacists have been told to return are Crestor, Seebri Breezhaler, Dovobet, Incruse and Spiriva.
Patients do not need to arrange a new prescription for these and can keep taking them until they run out.
The MHRA’s recall has been issued under its Falsified Medicines Directive, which regulates the security of the medicines supply chain in Europe.
But the UK regulator said there is no reason to believe there’s a problem with the production of the drugs involved, only that they may have been wrongly stored.
Storing drugs at temperatures outside of their optimum range can cause chemical changes which make them less effective, or lead liquids to separate or crystallise.
Certain concoctions may also become unstable if chemicals they contain can only dissolve in liquid between certain temperatures.
If someone’s medicine is affected in this way and doesn’t work properly, they may suffer damaging effects if they’re being treated for a serious illness.
It added: ‘The products are believed to be legitimate. There is no evidence that they have been tampered with and these medicines are stable at room temperature.’
|Product and Pack Size||Italian Batch Number||B & S Batch Number||Expiry Date||Date of First Distribution|
|Clexane 8000iu 0.8ml 1 x 10||7CK98A||04N0078||30-Oct-20||18-Apr-18|
|Clexane 8000iu 0.8ml 1 x10||7CH63B||04N0016||30-Jun-20||11-Apr-18|
|Clexane 8000iu 0.8ml 1 x 10||7CL23B||03N1722||30-Oct-20||22-May-18|
|Clexane 8000iu 0.8ml 1 x10||7CH36C||03N1721||30-Jun-20||11-Apr-18|
|Clexane 8000iu 0.8ml 1 x 10||7CH77B||03N1721||30-Jun-20||11-Apr-18|
|Clexane 8000iu 0.8ml 1 x 10||7CL82B||03N1720||30-Nov-20||11-May-18|
|Clexane 8000iu 0.8ml 1 x 10||7CL37D||03N1722||30-Oct-20||22-May-18|
|Clexane 8000iu 0.8ml 1 x 10||8CA66C||03N1716||30-Dec-20||10-May-18|
|Dovobet Gel 1 x 30g||A80960||11N0735||30-Jul-20||06-Dec-18|
|Dovobet Gel 1 x 30g||A79729||11N0734||30-Jun-20||05-Dec-18|
|Dovobet Gel 1 x 30g||A85747||01P0222||30-Oct-20||09-Jan-19|
|Dovobet Gel 1 x 30g||A78018||01P0850||30-May-20||16-Jan-19|
|Dovobet Gel 1 x 30g||A80960||01P0221||30-Jul-20||09-Jan-19|
|Dovobet Gel 1 x 30g||A87671||02P1199||30-Oct-20||02-Apr-19|
|Dovobet Gel 1 x 30g||A85936||02P1206||30-Oct-20||19-Mar-19|
|Dovobet Gel 1 x 30g||A85747||02P1207||30-Oct-20||29-Apr-19|
|Dovobet Gel 1 x 30g||A88301||02P1205||30-Nov-21||15-May-19|
|Dovobet Gel 1 x 30g||A80960||02P1204||30-Jul-20||30-Apr-19|
|Dovobet Gel 1 x 30g||A89721||04P0609||30-Nov-21||14-May-19|
|Dovobet Gel 1 x 30g||A90279||03P1677||30-Dec-21||12-Apr-19|
|Dovobet Gel 1 x 30g||A85936||03P1679||30-Oct-20||14-May-19|
|Incruse Inhaler 55Mcg 1 x 30 Doses||R829935||06N0036||30-Jun-19||07-Jun-18|
|Incruse Inhaler 55Mcg 1 x 30 Doses||R834141||05N0506||30-Sep-19||21-May-18|
|Incruse Inhaler 55Mcg 1 x 30 Doses||R839098||05N0750||30-Oct-19||23-May-18|
|Incruse Inhaler 55Mcg 1 x 30 Doses||R838744||05N0659||30-Oct-19||22-May-18|
|Incruse Inhaler 55Mcg 1 x 30 Doses||R844186||05N0657||30-Dec-19||21-May-18|
|Incruse Inhaler 55Mcg 1 x 30 Doses||R851918||11N0754||30-Mar-20||27-Nov-18|
|Incruse Inhaler 55Mcg 1 x 30 Doses||R856773||11N0753||30-Jul-20||21-Nov-18|
|Incruse Inhaler 55Mcg 1 x 30 Doses||R853231||11N0755||30-Mar-20||21-Nov-18|
|Incruse Inhaler 55Mcg 1 x 30 Doses||R849465||11N0752||28-Feb-20||22-Nov-18|
|Incruse Inhaler 55Mcg 1 x 30 Doses||R853231||01P0344||30-Mar-20||09-Jan-19|
|Incruse Inhaler 55Mcg 1 x 30 Doses||R851918||01P0345||30-Mar-20||09-Jan-19|
|Incruse Inhaler 55Mcg 1 x 30 Doses||R856773||12N0071||30-Jul-20||07-Dec-18|
|Incruse Inhaler 55Mcg 1 x 30 Doses||R858970||01P0343||30-Aug-20||09-Jan-19|
|Incruse Inhaler 55Mcg 1 x 30 Doses||R856773||12N0808||30-Jul-20||31-Dec-18|
|Incruse Inhaler 55MCg 1 x 30 Doses||R852223||01P0344||30-Mar-20||09-Jan-19|
|Incruse Inhaler 55Mcg 1 x 30 Doses||R858970||02P1201||30-Aug-20||11-Apr-19|
|Incruse Inhaler 55Mcg 1 x 30 Doses||R856773||02P1200||30-Jul-20||18-Apr-19|
|Incruse Inhaler 55Mcg 1 x 30 Doses||R851918||02P1209||30-Mar-20||18-Apr-19|
|Incruse Inhaler 55Mcg 1 x 30 Doses||R861997||03P0530||30-Sep-20||28-Mar-19|
|Incruse Inhaler 55Mcg 1 x 30 Doses||R860226||03P0991||30-Aug-20||27-Mar-19|
|Incruse Inhaler 55Mcg 1 x 30 Doses||R861997||03P0955||30-Sep-20||03-Apr-19|
|Incruse Inhaler 55Mcg 1 x 30 Doses||R860226||03P1676||30-Aug-20||05-Apr-19|
|Incruse Inhaler 55Mcg 1 x 30 Doses||R861997||03P1675||30-Sep-20||11-Apr-19|
|Incruse Inhaler 55Mcg 1 x 30 Doses||R861997||04P1150||30-Sep-20||29-Apr-19|
|Neupro 4mg/24hrs 1 x 28 Patches||56688403||05N0469||28-Feb-20||01-Jun-18|
|Neupro 4mg/24hrs 1 x 28 Patches||56679402||06N0592||30-Jan-20||14-Jun-18|
|Neupro 4mg/24hrs 1 x 28 Patches||56712404||10N1295||30-Jun-20||31-Oct-18|
|Neupro 4mg/24hrs 1 x 28 Patches||56722401||10N1292||30-Jul-20||02-Nov-18|
|Neupro 4mg/24hrs 1 x 28 Patches||56728403||10N1296||30-Aug-20||26-Oct-18|
|Neupro 4mg/24hrs 1 x 28 Patches||56722401||11N0650||30-Jul-20||23-Nov-18|
|Neupro 4mg/24hrs 1 x 28 Patches||56712403||11N0649||30-Jun-20||22-Nov-18|
|Neupro 4mg/24hrs 1 x 28 Patches||56742401||11N0651||30-Nov-20||06-Dec-18|
|Neupro 4mg/24hrs 1 x 28 Patches||56728403||11N0647||30-Aug-20||26-Nov-18|
|Neupro 4mg/24hrs 1 x 28 Patches||56712404||11N0648||30-Jun-20||26-Nov-18|
|Neupro 4mg/24hrs 1 x 28 Patches||56699404||04P1286||30-Apr-20||14-May-19|
|Neupro 4mg/24hrs 1 x 28 Patches||56728403||01P0366||30-Aug-20||14-Jan-19|
|Neupro 4mg/24hrs 1 x 28 Patches||56742401||01P0314||30-Nov-20||09-Jan-19|
|Neupro 4mg/24hrs 1 x 28 Patches||56757104||04P1278||30-Jan-21||03-May-19|
|Neupro 4mg/24hrs 1 x 28 Patches||56763103||04P1279||30-Jan-21||03-May-19|
|Provisacor (Sold as Crestor) 10Mg Tabs 1 x 28||U733A||04N1584||30-Apr-20||08-May-18|
|Provisacor (Sold as Crestor) 10Mg Tabs 1 x 28||U571A||05N0155||28-Feb-20||29-May-18|
|SEEBRI BREEZHALER 44mg 1 x 30 Doses||BFD79||04PO113||30-Jul-20||18-Apr-19|
|Spiriva Inhalation Powder 18mcg Cap 1 x 30||802223||01P0226||28-Feb-20||09-Jan-19|
|Spiriva Inhalation Powder 18mcg Cap 1 x 30||804102||01P0227||30-May-20||09-Jan-19|
|VIMPAT 100MG TABS 1 X 56||254265||01P0324||30-Apr-23||11-Jan-19|
|VIMPAT 100MG TABS 1 X 56||255279||02P1067||30-Apr-23||19-Mar-19|
|VIMPAT 100MG TABS 1 X 56||258582||02P0892||30-Jun-23||25-Mar-19|
|VIMPAT 100MG TABS 1 X 56||254265||02P0893||30-Apr-23||25-Mar-19|