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Updates

SUB-TYPE: CLASS 4 CAUTION IN USE

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

 

Pip code

Product description

Supplier

Batch Numbers

7042013

PI BEZALIP MONO TABLETS 400MG (30)

QUADRANT PHARMACEUTICALS LIMITED

J3594

J3741

J3943

K0077

K0310

K0327

K0455

K0547

K0549

K0562

K2019

K1994

K2196

K2274

K2742

K2943

K3158

K3134

 

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.

SUB-TYPE: CLASS 2 RECALL

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

 

Pip code

Product Description

Supplier

Batch Numbers

ALLIANCE DO NOT STOCK

LORAZEPAM 2MG/ML INJECTION (UNLICENSED MEDICINES)

HIKMA PHARMACEUTICALS USA INC

070084

070126

080060

080091

ALLIANCE DO NOT STOCK

LORAZEPAM 4MG/ML INJECTION (UNLICENSED MEDICINES)

HIKMA PHARMACEUTICALS USA INC

070096

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.

SUB-TYPE: CLASS 2 RECALL

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

 

 

   Pip code         

          Product Description           

        Supplier          

   Batch Numbers   

 ALLIANCE DO

  NOT STOCK

     Dysport 500 Units Powder

       for Solution for Injection

    Ipsen Limited

        U14534

 

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.

 

SUB-TYPE: CLASS 4 CAUTION IN USE

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

 

 

Pip code

Product description

Livery

Batch Numbers

1220268

Rosuvastatin 5 mg film-coated tablets

   ACCORD HEALTHCARE LIMITED

P2102389

1220250

Rosuvastatin 10 mg film-coated tablets 

   ACCORD HEALTHCARE LIMITED

P2103803

1220243

Rosuvastatin 20 mg film-coated tablets

   ACCORD HEALTHCARE LIMITED

P2104132

 

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

 

 

 

 

 

 

 

 

 

SUB-TYPE: CLASS 2 RECALL

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

 

Pip code

Product description

Livery

Batch Numbers

1186964

Zoledronic acid SUN 5mg solution for infusion

SUN PHARMA UK

JKX5541B
HAC1087A
HAC3395A
HAD0156B

 

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.

 

 

SUB-TYPE: COMPANY-LED RECALL

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

 

Pip code

Product

Supplier

Affected Batches

ALLIANCE DO NOT STOCK

Sodium Chloride Eye Drops 5% 1x10ml

Stockport Pharmaceuticals

C104308

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.

SUB-TYPE: CLASS 1 RECALL

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

Pip code

Product description

Livery

Batch Numbers

8040990

MEXILETINE CAP 50MG (84)

CLINIGEN HEALTHCARE LTD

2111216

8041006

MEXILETINE CAP 100MG (84)

CLINIGEN HEALTHCARE LTD

2111217

8041014

MEXILETINE CAP 200MG (100)

CLINIGEN HEALTHCARE LTD

2111218

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.

SUB-TYPE: CLASS 4 CAUTION IN USE

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

 

Pip code

Product Description

Supplier

Batch Numbers

4089983

NIQUITIN PATCH CLEAR 14MG X 14

OMEGA PHARMA LIMITED

0370102

1110101

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

SUB-TYPE: CLASS 4 CAUTION IN USE

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

 

Pip code

Product Description

Supplier

Batch Numbers

3667698

INS NOVORAPID

FLEXTOUCH X 5

NOVO NORDISK LIMITED

MZF0M05

MZF1H04

4154209

SAXENDA 6MG/ML

PREFILLED PEN 3ML X 3

NOVO NORDISK LIMITED

LZF0H19

LZF0D36

LZFW142

MZF0V95

4028676

SAXENDA 6MG/ML

PREFILLED PEN 3ML X 5

NOVO NORDISK LIMITED

LZFW572

LZF0D41

LZFW571

LZFY408

LZFY613

MZF1B51

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

SUB-TYPE: CLASS 2 RECALL

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

 

Pip code

Product Description

Supplier

Batch Numbers

ALLIANCE DO NOT STOCK

AMIODARONE HYDROCHLORIDE 50 MG/ML CONCENTRATE FOR SOLUTION FOR INJECTION-INFUSION

HAMELN PHARMA LTD

207506

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