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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

SUB-TYPE: CLASS 4 CAUTION IN USE

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

 

Pip codeProduct DescriptionSupplierBatch Numbers
2469385Covonia Night Time Formula 150ml (P)Thornton & Ross00JE
80JG
322537Covonia Original Bronchial Balsam 150ml (P)Thornton & Ross69KE
81KR

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

SUB-TYPE: COMPANY-LED RECALL

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

 

Pip code

Product

Supplier

Affected Batches

ALLIANCE DO NOT STOCK

LINOFORCE GRANULES 12 YEARS PLUS

A.VOGEL LTD

1064615

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.

SUB-TYPE: COMPANY-LED RECALL

Company Led Recall - Invita D3 800 IU Soft Capsules (28)

Consilient Health UK Ltd is recalling a specific batch due to limited units from the batch being distributed prior to batch release.

Limited number of units from the batch were distributed prior to batch release. There are no indications of any quality of safety concerns and this recall is precautionary due to the regulatory non-compliance.

This recall is being issued as a company-led medicines recall, as this product is only supplied to several pharmacies and the company has 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: 30 May 2022

 

MHRA drug alert link:

https://www.gov.uk/drug-device-alerts/company-led-medicines-recall-consilient-health-uk-ltd-invita-d3-800-iu-soft-capsules-clmr-22-a-slash-03?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=af199a05-a42d-45cf-92c1-c989034c465e&utm_content=immediately

 

Pip code

Product description

Supplier

Affected Batches

4039764

INVITA D3 800 IU CAP (28)

CONSILIENT HEALTH UK LTD

1389492

 

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.

 

If you have any questions, then please contact your local Service Centre Customer Services team.

SUB-TYPE: CLASS 2 RECALL

Class 2 Recall - Phenobarbital 60mg Tablets

Bristol Laboratories Limited are recalling the below batch of product as a precautionary measure due to low dissolution test results reported during ongoing stability studies.

 

MHRA drug alert date: 13 June 2022

 

MHRA drug alert link:  https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-bristol-laboratories-limited-phenobarbital-60-mg-tablets-el-22-a-slash-28?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=340f3212-3993-49a9-9f24-fc5419d8fcc2&utm_content=immediately

 

Pip code

Product Description

Supplier

Batch Numbers

ALLIANCE DO NOT STOCK

PHENOBARBITAL 60MG TABLETS

BRISTOL LABORATORIES LIMITED

NW0001

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

 

Further Information
For more information, medical or supply enquiries, please contact notifications@bristol-labs.co.uk

 

Recipients of this Medicines Recall should bring it to the attention of relevant contacts by copy of this notice.

SUB-TYPE: CLASS 2 RECALL

Class 2 Recall - Water for Injections BP – 100ml vial x 25

Hameln pharma ltd are recalling batches of product additional to the batch recalled on 15 February 2022 (reference EL(22)A/06). 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 the parameters pH and conductivity.

 

MHRA drug alert date: 25 May 2022

 

MHRA drug alert link: https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-hameln-pharma-ltd-water-for-injections-bp-100ml-vial-el-22-a-slash-24?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=5178b109-19c7-4882-b7e7-ee9285e62098&utm_content=immediately

 

Pip code

Product description

Supplier

Batch Numbers

0769489

WATER FOR INJ BP VIAL R/C 100ML (25)

HAMELN PHARMACEUTICALS LTD (MOV)

019501

019502

019503

019504

019505

019506

920503

920506

920508

930503

930504

930505

931501

940501

940502

951504

952501

Further Information

 

For more information, medical or supply enquiries, please contact: drug.safety@hameln-pharma.co.uk

 

For stock control queries, please contact: customer.services@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.

 

Please note that anything not returned to us, or notified to us, within 3 months of this notification by the 26 August 2022, cannot be reimbursed by way of a credit

SUB-TYPE: CLASS 2 RECALL

Class 2 Recall - Mefenamic Acid 500mg film coated, 30 tablets

Quadrant Pharmaceuticals Ltd are recalling a specific batch of Mefenamic Acid 500mg Film-Coated, 30 Tablets as a precautionary measure, due to observations of a defective layer of film coating in some tablets, resulting in the tablet core being partially exposed.

 

MHRA drug alert link:

https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-quadrant-pharmaceuticals-ltd-mefenamic-acid-500mg-film-coated-tablets-el-22-a-slash-23?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=bc363bcf-f3dc-4fbf-9017-327ecb34cd6f&utm_content=immediately

 

Pip code

Product Description

Supplier

Batch Numbers

ALLIANCE DO NOT STOCK

MEFENAMIC ACID 500MG FILM COATED, 30 TABLETS

QUADRANT PHARMACEUTICALS LTD

107082

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

 

Further Information

 

For more information, medical or supply enquiries, please contact joanne.fishwick@maxearn.co.uk or radoslaw.bandomir@maxearn.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.

SUB-TYPE: CLASS 4 CAUTION IN USE

Class 4 Drug Caution In Use - Zovirax I.V. 500mg

GlaxoSmithKline UK Ltd have informed the MHRA that an incorrect version of the Summary of Product Characteristics section 4.2 and the Patient Information Leaflet is inside the sealed pack, and contains unapproved text.

 

MHRA drug alert link:

https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-glaxosmithkline-uk-ltd-zovirax-iv-500-mg-el-22-a-slash-22?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=2fba3ba7-af6b-48f5-bcb3-903db16db3f2&utm_content=immediately

 

Pip code

Product description

Supplier

Batch Numbers

489633

ZOVIRAX IV VIAL 500MG

GLAXOSMITHKLINE UK LTD

9G4B

TC8E-A

6V8W

GN8S

J69C

B35J

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

 

Further Information

If you have any questions, please contact GSK UK Ltd Medical Information Department on 0800 221 441 or email: ukmedinfo@gsk.com