Class 4 Medicines Defect Information: Flamingo Pharma UK Ltd, Ibuprofen 400mg Tablets, Paracetamol 500mg Tablets (Caplets)

Flamingo Pharma UK Ltd has identified an error relating to the ink printing of the batch number and expiry date on the carton for three batches of Ibuprofen 400mg Tablets. This notification includes all potentially impacted products/batches.

MHRA drug alert date:  12th October 2022

MHRA drug alert link: 

https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-flamingo-pharma-uk-ltd-ibuprofen-400mg-tablets-paracetamol-500mg-tablets-caplets-el-22-a-slash-43?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=ffbd7a57-60fc-4de6-afd0-d1d3fb960b3e&utm_content=immediately#download-document

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:

Flamingo Pharma

For medical information safety@flamingopharma.co.uk or general product enquiry sales@flamingopharma.co.uk +44 (0) 7733522465

Or

Mawdsley Brooks & Co Ltd

Overlabellingcustomerservices@mawdsleys.co.uk 01302 553064

Recipients of this Medicines Notification 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 2 RECALL - AMIODARONE HYDROCHLORIDE 50MG/ML SOLUTION FOR INJECTION/INFUSION

hameln pharma ltd is initiating a recall of batch 210505 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: 11 October 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-42?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=8736ec08-585b-4e2f-9985-026dc8594eef&utm_content=immediately

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

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

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 2 RECALL - STEMETIL 5MG/5ML SYRUP

Sanofi is recalling all batches of the above product as a precautionary measure due to the identification of N-nitrosomethylphenylamine (NMPA) above the acceptable limit. Nitrosamines may increase the risk of cancer if people are exposed to them above acceptable levels and over long periods of time.

MHRA drug alert date: 10 October 2022

MHRA drug alert link: https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-aventis-pharma-limited-t-slash-a-sanofi-stemetil-5mg-slash-5ml-syrup-el-22-a-slash-41?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=8744b402-2664-40d4-a81b-0fbedeefc431&utm_content=immediately

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

For stock control enquiries please contact:

GB-CustomerServices@sanofi.com

Phone number: 0800 854 430

For more information or medical information please contact:

uk-medicalinformation@sanofi.com

Phone number: 0800 035 25 25.

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 2 RECALL - SANDIMMUN ORAL SOLUTION

Class 2 Recall -  Sandimmun Oral Solution

Novartis Pharmaceuticals UK are recalling the above batch due to the presence of crystals in the solution. The crystals have been identified as the active substance (ciclosporin). The presence of crystals has been observed in some finished product packs marketed in other countries that share the same master batch as the UK batch above. Therefore, this UK batch is recalled as a precautionary measure. Novartis Pharmaceuticals UK have confirmed no other batches of the product are impacted.

MHRA drug alert date: 20 September 2022

MHRA drug alert link: https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-novartis-pharmaceuticals-uk-sandimmun-oral-solution-el-22-a-slash-40?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=8bfa30ef-b0bd-4cf8-8ca4-e989982960bf&utm_content=immediately

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

Further Information For more information, medical or supply enquiries. 

Please contact 01276 698370, or email medinfo.uk@novartis.com

Class 4 Medicines Defect Information

Rosemont Pharmaceuticals Ltd. has made the MHRA aware that the expiry dates stamped on the base of the bottle are incorrect for 2 batches of Atorvastatin 4mg/ml Oral Suspension and 2 batches of Sildenafil 10mg/ml Oral Suspension.

MHRA drug alert date:  14 September 2022

MHRA drug alert link: https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-rosemont-pharmaceuticals-ltd-atorvastatin-4mg-slash-ml-oral-suspension-and-sildenafil-10mg-slash-ml-oral-suspension-el-22-a-slash-39

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, medical or supply enquiries, please contact: pharmacovigilance@rosemontpharma.com

Recipients of this Medicines Notification 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: PI Bezalip Mono 400mg Tablets (30)

Quadrant Pharmaceuticals Limited have informed the MHRA of an error with the Patient Information Leaflets (PILs) that have been packaged in various parallel imported batches.

MHRA drug alert date:  12 September 2022

MHRA drug alert link: 

https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-quadrant-pharmaceuticals-limited-bezalip-mono-400mg-tablets-el-22-a-slash-38?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=c4d6884b-4d39-4d67-851d-d24ae91bb6dc&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, medical or supply enquiries, please contact radoslaw.bandomir@maxearn.co.uk or natalie.harrison@hallohealthcaregroup.com

Recipients of this Medicines Notification 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 2 Recall - Lorazepam 2mg/ml Injection, Lorazepam 4mg/ml Injection (unlicensed medicines)

Hikma Pharmaceuticals USA Inc are recalling the above batches due to an out of specification result with related substances during testing for retain samples. This unlicensed medicine has been imported into the U.K. to meet the special need of individual patients.

MHRA drug alert date: 30 August 2022

MHRA drug alert link:

https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-hikma-pharmaceuticals-usa-inc-lorazepam-2mg-slash-ml-injection-lorazepam-4mg-slash-ml-injection-unlicensed-medicines?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=7ee36a17-10d8-4ee0-9c10-11b3163d55c3&utm_content=immediately

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

Further Information

For more information or medical enquiries, please contact pv@hikma.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 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.