Class 2 Recall - Dysport 500 Units Powder for Solution for Injection

The Medicines and Healthcare products Regulatory Agency (MHRA) has been investigating a report of a falsification of the above product in the UK. The UK Marketing Authorisation Holder has confirmed that the batch above is falsified and has been supplied by unauthorised distributors to the UK.

MHRA drug alert date: 22 August 2022

MHRA drug alert link: https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-dysport-500-units-powder-for-solution-for-injection-el-22-a-slash-36?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=c9c55a5d-d085-47ca-ac0a-6898ac48c6e8&utm_content=immediately

Alliance do not stock the above product so we will not be accepting Customer returns on this recall.

Further Information

For medical information enquiries, please contact Ipsen Limited at medinfo.uk-ie@ipsen.com

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.

Class 4 Medicines Defect Information, Rosuvastatin 5 mg, 10 mg and 20 mg film-coated tablets

Further to a previous defect notification, Accord Healthcare have informed us of an error with the patient information leaflets (PILs) that have been packaged in the below additional batches of products. These were an older version of the PIL which did not include the most up to date safety information.

MHRA drug alert date: 17 August 2022

MHRA drug alert link: https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-rosuvastatin-5-mg-10-mg-and-20-mg-film-coated-tablets-el-22-a-slash-35?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=2afcaac8-d857-4b18-9d33-b81088d65e0c&utm_content=immediately

This is a caution in use only we are not accepting stock returns - if any defective stock is found it should be returned directly to the manufacturer.

Further Information

For more information or medical information queries please contact: Accord Medical Information Department on 01271 385257, email medinfo@accord-healthcare.com.

For stock control queries, please contact: Accord Customer Services Team on 0800 373573

For updated PIL requests please contact contact@accord-healthcare.com or phone: 01271 385200

Class 2 Recall - Zoledronic acid SUN 5mg solution for infusion

Sun Pharmaceuticals are recalling the below batches of zoledronic acid due to out of specification results observed for Particulate Matter Test during routine stability testing. This recall is conducted as a precautionary measure as remaining vials may no longer be in line with the licensed product specification with respect to particulate matter.

MHRA drug alert date  11 August 2022

MHRA drug alert link:

https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-sun-pharmaceutical-industries-europe-bv-zoledronic-acid-sun-5mg-solution-for-infusion-el-22-a-slash-34?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=7554e8e8-c653-4070-8512-bf893507e32a&utm_content=immediately

Further Information

For more information, medical or supply enquiries, please contact:

Maciej Rosiak (Qualified Person), +31612091885; maciej.rosiak@sunpharma.com  or

Gene Kelleher (Head Quality Europe), +353 86 344 1145; gene.kelleher@sunpharma.com

Please return all affected stock to your original supplier for credit. Unfortunately, we can only accept stock purchased from us (Alliance Healthcare Distribution Limited). Any other stock will be returned to your stores/Pharmacies.

Please note that anything not returned to us, or notified to us, within 3 months of this notification, cannot be reimbursed by way of a credit.

Company Led Recall - Sodium Chloride Eye Drops 5% 1x10ml

Stockport Pharmaceuticals are recalling a batch of Sodium Chloride Eye Drops 5% w/v as the sterile eye droppers supplied with the medicinal product have expired (January 2022).

MHRA drug alert date: 8 August 2022

MHRA drug alert link:

https://www.gov.uk/drug-device-alerts/company-led-medicines-recall-stockport-pharmaceuticals-sodium-chloride-eye-drops-5-percent-1x10ml-unlicensed-medicine-clmr-22-a-slash-06?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=5ad08b90-ab91-4591-ba3a-222f557b2a96&utm_content=immediately

Alliance do not stock this product and therefore we are not accepting stock returns.

Company Contact for medical information enquiries

For medical information enquiries, please contact:

Emma Joy Wraith

Head of Quality Assurance

Email: Emma-joy.wraith@stockport.nhs.uk 

Company Contact for stock enquiries

For stock information enquiries, please contact:

Andrew Singleton

Head of Production

Email: Andrew.singleton@stockport.nhs.uk

Please return all affected stock to your original supplier for credit. Unfortunately we can only accept stock purchased from us (Alliance Healthcare Distribution Limited). Any other stock will be returned to your stores/Pharmacies.

CLASS 1 RECALL - MEXILETINE HYDROCHLORIDE 50MG, 100MG AND 200MG HARD CAPSULES

Clinigen Healthcare Ltd is initiating a recall of three batches of Mexiletine hydrochloride hard capsules due to a potential risk of underdose or overdose, which could have consequences for the safety of patients.

MHRA drug alert date:  4 August 2022

MHRA drug alert link: 

https://www.gov.uk/drug-device-alerts/national-patient-safety-alert-class-1-medicines-recall-notification-recall-of-mexiletine-hydrochloride-50mg-100mg-and-200-mg-hard-capsules-clinigen-healthcare-ltd-due-to-a-potential-for-underdosing-and-slash-or-overdosing-natpsa-s?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=a1c1fa91-a26a-40a3-a473-d720cced6b0b&utm_content=immediately

Further information

For more information or stock and resupply queries, please contact Quantum Pharmaceutical +44 (0) 1207 279 400 or email enquiries@quantumpharma.co.uk

For medical information queries, please contact Clinigen Medical Information on +44 (0) 1932 824 026 or email medicalinformation@clinigengroup.com

For all other enquires place contact Clinigen Healthcare Ltd on +44 (0) 1283 494 340 or email medicineaccess@clinigengroup.com

Please return all affected stock to your original supplier for credit. Unfortunately we can only accept stock purchased from us (Alliance Healthcare Distribution Limited). Any other stock will be returned to your stores/Pharmacies.

Please note that anything not returned to us, or notified to us, within 3 months of this notification, cannot be reimbursed by way of a credit.

Class 4 Drug Caution In Use - Niquitin 14mg Clear Patch x 14

Omega Pharma Limited have identified an error relating to the product packaging. In the ‘Ingredients’ section on the base of the carton, the patch dosage is stated as providing 21mg of nicotine per day. The correct dosage is 14mg per day. The other dosage indications on the carton, the sachets, PIL and SmPC are correct. There is no issue with the product quality and the batch is not being recalled.

MHRA drug alert date: 20 July 2022

MHRA drug alert link:

https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-omega-pharma-limited-niquitin-14mg-clear-patch-14-patches-el-22-a-slash-32?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=e4ca04d0-7b49-4bf4-ac21-370254221350&utm_content=immediately

This is a caution in use only we are not accepting stock returns - if any defective stock is found it should be returned directly to the manufacturer.

Further Information

For medical information and stock control queries please contact: uklocustomerservice@perrigo.com

Class 4 Drug Caution In Use - NovoRapid FlexTouch 100 units/ml and Saxenda FlexTouch® (liraglutide) 6mg/ml

Novo Nordisk Limited would like to notify you of a defect that affects specific batches of NovoRapid FlexTouch prefilled pen device and batches of Saxenda FlexTouch prefilled pen device in the UK. The defect results in a non-functioning device where it is not possible to set a dose because the dose selector will spin freely, as such, click sounds will not be heard. Since a dose cannot be selected, the patient cannot inject a dose. A very small number of pens are affected – the average number of affected products is 2-3 pens per million pens. Based on the critical need for the products, they are not being recalled.

MHRA drug alert date: 21 July 2022

MHRA drug alert link:

https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-novo-nordisk-limited-novorapid-r-flextouch-r-100-units-slash-ml-saxenda-r-flextouch-r-liraglutide-6mg-slash-ml-el-22-a-slash-33?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=d1821ab9-5a71-4493-a0b8-973140c8ca04&utm_content=immediately

This is a caution in use only we are not accepting stock returns - if any defective stock is found it should be returned directly to Novo Nordisk Limited.

Further Information

For medical information and stock control queries please contact: Customer Care contact details +44 (0)800 023 2573 or CustomerCare@novonordisk.com

Class 2 Recall - Amiodarone Hydrochloride 50mg/ml Concentrate for Solution for Injection/Infusion

Hameln pharma ltd is initiating a recall of batch 207506 of Amiodarone Hydrochloride 50 mg/ml Concentrate for Solution for Injection/Infusion as a precautionary measure. This is due to an increased presence of visible crystalline particles within the solution, identified during ongoing re-inspection of retained samples.

MHRA drug alert date: 19 July 2022

MHRA drug alert link:

https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-hameln-pharma-ltd-amiodarone-hydrochloride-50-mg-slash-ml-concentrate-for-solution-for-injection-slash-infusion-el-22-a-slash-31?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=fa9877a9-7754-4352-bb81-906f9407cb81&utm_content=immediately

Alliance do not stock the above product so we will not be accepting Customer returns on this recall.

Further Information

For more information or supply queries, please contact or email Hameln pharma ltd customer services on +44 (0)1452 621 661 or customer.services@hameln-pharma.co.uk

For medical information queries, please contact or email Hameln pharma ltd Medicines Information on +44 (0)1452 621 661 or drug.safety@hameln-pharma.co.uk

Class 4 Drug Caution In Use - Covonia Night Time Formula & Covonia Original Bronchial Balsam

Thornton & Ross have identified that the product labelling for some batches of ‘Pharmacy’ medicines do not contain the ‘P’ symbol, due to a packaging error on the bottle.

MHRA drug alert date: 14 July 2022

MHRA drug alert link:

https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-thornton-and-ross-covonia-night-time-formula-and-covonia-original-bronchial-balsam-el-22-a-slash-30?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=1610a023-5b61-41a6-a141-8768fd5f9c85&utm_content=immediately

This is a caution in use only we are not accepting stock returns.

Further Information

For medical information or stock control queries please contact : Thornton & Ross on 01484 842217 or thorntonross@medinformation.co.uk

Company Led Recall - Linoforce granules 12 years plus

A.Vogel Ltd is recalling the above batch of Pharmacy only medicine due to a small number of packs that were inadvertently supplied to non-pharmacy retail outlets.

This recall is being issued as a company-led medicines recall as this product is only supplied to several outlets, and the manufacturer has full traceability of the onward distribution by their customers.

Remaining stock of the above batch should be quarantined and returned to the company directly.

MHRA drug alert date: 22 June 2022

MHRA drug alert link:

https://www.gov.uk/drug-device-alerts/company-led-medicines-recall-avogel-ltd-linoforce-granules-12-years-plus-thr-13668-slash-0021-clmr-22-a-slash-05?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=9a9d096a-2ab5-48fb-93c4-731c29c2c6cd&utm_content=immediately

Alliance do not stock this product and therefore we are not accepting stock returns.

For medical information enquiries, please contact:

Gillian Forrest

A..Vogel Ltd

2 Brewster Place

Irvine

Ayrshire

KA11 5DD

Email: gillian@avogel.co.uk

For stock information enquiries, please contact:

Debbie Martin

A.Vogel Ltd

2 Brewster Place

Irvine

Ayrshire

KA11 5DD

Email: debbie@avogel.co.uk

Please return all affected stock to your original supplier for credit. Unfortunately we can only accept stock purchased from us (Alliance Healthcare Distribution Limited). Any other stock will be returned to your stores/Pharmacies.