Ticker Update

COMPANY LED - IRINOTECAN 200MG/ 260ML IN SODIUM CHLORIDE 0.9% W/V INTRAVENOUS INFUSION AND INFLIXIMAB (REMSIMA) INTRAVENOUS INFUSION IN SODIUM CHLORIDE 0.9%

Qualasept Ltd t/a Bath ASU is recalling a specific batch of Irinotecan 200mg/260mL in sodium chloride 0.9% w/v intravenous infusion and specific batches of Infliximab (Remsima) Intravenous infusion in Sodium Chloride 0.9%w/v due to risks of reduced product quality

MHRA drug alert link https://www.gov.uk/drug-device-alerts/company-led-medicines-recall-irinotecan-200mg-slash-260ml-in-sodium-chloride-0-dot-9-percent-w-slash-v-intravenous-infusion-and-infliximab-remsima-intravenous-infusion-in-sodium-chloride-0-dot-9-percent?utm_medium=email&utm_campaign=govuk-notifications&utm_source=46e56b1e-074c-4df7-b8da-04593bef0bdc&utm_content=immediately     

Please note that Alliance Healthcare do not stock and we are not accepting stock returns.

Company Contact for medical information enquiries

For medical information enquiries, please contact Maria Connolly:

Tel: 01225 811131

Maria.connolly@bathasu.com

Company Contact for stock enquiries

For stock information enquiries,

Tel: 01225 811131

customerservices@bathasu.com

CLASS 2 RECALL - CHAMPIX (ALL STRENGTHS) FILM-COATED TABLETS

Champix (varenicline tartrate) is indicated for smoking cessation in adults. Upon request from MHRA, Pfizer Ltd are recalling specified batches (all stock) of products as a precautionary measure due to presence of levels of N-nitroso-varenicline above the acceptable level of intake set by both European Medicines Agency (EMA) and MHRA. The recall is at pharmacy and wholesaler level

MHRA drug alert link: https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-pfizer-ltd-champix-all-strengths-film-coated-tablets-el-21-a-slash-25?utm_medium=email&utm_campaign=govuk-notifications&utm_source=97cdd42e-9465-4f68-a92e-8ad9b4d937f3&utm_content=immediately   

Please note that we do not stock the PI Livery listed in the attached document from the MHRA and returns will not be accepted.

Further Information

Pfizer is aware of the current supply constraints related to this product and is working to resolve the issue and resume manufacturing. Further updates relating to potential resupply will be communicated in due course.

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

For medical information enquiries, please contact Pfizer Medical Information Department on 01304 616161.

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 2 RECALL - TESCO FLU-MAX ALL IN ONE CHESTY COUGH & COLD POWDER FOR ORAL SOLUTION (GSL)

Perrigo are recalling the below batches due to an error on the sachet contained within the outer carton. The sachet artwork incorrectly states that children aged 12 years and over can take 4 sachets containing 1000mg of paracetamol (i.e. 4 doses over a 24 hour period), whereas the carton, PIL and SmPC state that the product is not to be given to the under 16s. The sachets dosage instructions are those which were in use prior to the paediatric paracetamol posology update implemented by the MHRA

MHRA drug alert link: https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-tesco-flu-max-all-in-one-chesty-cough-and-cold-powder-for-oral-solution-wrafton-laboratoires-limited-trading-as-perrigo-el-21-a-slash-24?utm_medium=email&utm_campaign=govuk-notifications&utm_source=fc6820b1-8e07-4240-bef5-cf828442556f&utm_content=immediately

Please note that Alliance Healthcare do not stock and we are not accepting stock returns.

Further Information

For more information, please contact: Perrigo Customer Services Team on 0203 598 9603 or UKLOCustomerService@perrigo.com

For stock control queries, please contact: Perrigo Service Team on 01226 704711 or customerservice@perrigouk.com

CLASS 2 RECALL - LEVOTHYROXINE TABLETS BP 50 MICROGRAMS

NorthStar are recalling the below batch of Levothyroxine Tablets BP 50 micrograms as a precautionary measure due to out of specification results for tablet hardness obtained during stability testing. This issue may result in tablets that crumble or break when removed from the packaging.

MHRA drug alert link: https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-accord-uk-ltd-trading-style-northstar-levothyroxine-tablets-bp-50-micrograms-el-21-a-slash-23?utm_medium=email&utm_campaign=govuk-notifications&utm_source=81eb29f8-dc8c-4b55-a257-c872a529afa5&utm_content=immediately   

Further Information

For more information or medical information queries, please contact: NorthStar Medical Information Department on 01271 385257

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

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.

CLASS 2 RECALL - IKERVIS 1 MG/ML EYE DROPS

SANTEN Oy (trading as Santen UK Limited) are recalling the below batches of products as a precautionary measure due to detection of particles/crystals of the active pharmaceutical ingredient ciclosporin. These particles have been detected following microscopic evaluation during stability monitoring. The company’s root cause investigation is ongoing

MHRA drug alert link: https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-santen-oy-trading-as-santen-uk-limited-ikervis-1-mg-slash-ml-eye-drops-emulsion-el-21-a-slash-22?utm_medium=email&utm_campaign=govuk-notifications&utm_source=ee7f731a-c906-4ee1-8c07-9626285185c8&utm_content=immediately

Please note that Alliance Healthcare do not stock and we are therefore not accepting stock returns.

For more information, please contact Santen UK Limited, Salisbury Hall, St Albans, AL2 1BU, UK at +44 (0)1727 615 110 or email enquiries@santen.co.uk

For medical information queries, please contact 0345 075 4863 or email medinfo@santen.co.uk

For supply queries, please contact AAH Customer services at 0344 561 8899

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

Class 4 Drug Caution in use - ROSUVASTATIN 5 MG, 10 MG, 20 MG AND 40 MG FILM-COATED TABLETS

Accord Healthcare have informed us of an error with the patient information leaflets (PILs) that have been packaged in the below 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 link: https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-rosuvastatin-5-mg-10-mg-20-mg-and-40-mg-film-coated-tablets-el-21-a-slash-21?utm_medium=email&utm_campaign=govuk-notifications&utm_source=3e06cb87-f3cb-4338-896d-f0082c18f7f1&utm_content=immediately     

This may have been supplied by AHDL. Unfortunately we are not providing specific batch information you will  be required to follow the instructions as per the drug alert.

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

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.

FIELD SAFETY NOTICE - AQUACEL AG+ EXTRA 20X30CM(1X5PK)

ConvaTec are voluntarily initiating a field action for the below-stated product because a complaint has been received for an open seam on the primary packaging and also showing the dressing partially stuck within the seal. This has therefore breached the sterile barrier and made the product unable to be used. Using a non-sterile device on a patient may potentially expose the patient to infectious agents

MHRA drug alert link: N/A   

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.

CLASS 2 RECALL - METFORMIN SF SUS 500MG/5ML

Rosemont Pharmaceuticals Limited is recalling all unexpired stock of the below product from pharmacies and wholesalers as a precautionary measure due to the identification level of an impurity above the acceptable limit. Following routine monitoring, the impurity, N-nitrosodimethylamine (NDMA) which has genotoxic and carcinogenic potential, has been observed at a level above the acceptable limit

MHRA drug alert link: https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-rosemont-pharmaceuticals-limited-metformin-hydrochloride-500mg-slash-5ml-oral-solution-pl-00427-slash-0139-el-21-a-slash-20?utm_medium=email&utm_campaign=govuk-notifications&utm_source=c8cb9f63-892e-4ac7-826d-54d8b20db482&utm_content=immediately  

Further Information

For stock control enquiries please contact: Customerservices@rosemontpharma.com

For medical information enquiries please contact: pharmacovigilance@rosemontpharma.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.

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

CLASS 2 RECALL - VARIOUS SUPPLIER & PRODUCTS

Specific batches of the below products are recalled by the Marketing Authorisation Holders and parallel distributor companies as a precautionary measure due to contamination with an impurity called 5-(4’- (azidomethyl)-[1,1’-biphenyl]-2yl)-1H-tetrazole, which has mutagenic potential. These batches are being recalled as the level of contamination is above the acceptable limit

MHRA drug alert link: https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-various-marketing-authorisation-holders-and-parallel-distributor-companies-irbesartan-containing-products-el-21-a-slash-19?utm_medium=email&utm_campaign=govuk-notifications&utm_source=7fde90cb-19d4-417d-888c-d7769dcf3f3f&utm_content=immediately   

Please can you ensure that your stores quarantine the product listed below.

Aventis Pharma Limited T/A Sanofi

Zentiva

Parallel Distributors

Doncaster Pharmaceuticals Group Ltd

MPT Pharma Limited

PCO Manufacturing Ltd

Gowrie Laxmico Ltd T/A B&S Healthcare

Further Information

Sanofi

For stock control enquiries, please contact GB-CustomerServices@sanofi.com or 0800 854 430

For more information or medical information queries, please contact uk-medicalinformation@sanofi.com

or 0800 035 25 25

Doncaster Pharmaceuticals Group Ltd

For more information or medical information queries, please contact Richard Gore at 01302 554805 (or

07736 297267 out of hours) or richard.gore@doncaster-pharm.com

For supply queries, please contact Rebecca Platts at 01302 552961 (Mon-Fri 8am-4pm) or

rebecca.platts@doncaster-pharm.com

MPT Pharma Limited

For more information or medical information queries, please contact qa@cstpharma.co.uk or tel 01477

549310

For supply queries, please contact: qa@cstpharma.co.uk or tel 01477 549310

EL (21)A/19 Page 4 of 4

PCO Manufacturing Ltd

For more information or medical information queries, please contact Niamh Clarke at nclarke@pco.ie

For supply queries, please contact Jason Ogle at jogle@nippharma.co.uk

Gowrie Laxmico Ltd T/A B&S Healthcare

For more information or medical information queries, please contact medinfo@bnsheathcare.com

For supply queries, please contact customerservice@bnshealthcare.com

Zentiva Pharma UK Ltd

For more information or medical information queries, please contact 0800 0902408 or

UKmedinfo@zentiva.com

For supply queries, please contact 0844 8793188 or gfd-customerservices@zentiva.com. Please contact

claims@zentiva.com to arrange return and replacement of affected packs in your possession.

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.

FIELD SAFETY NOTICE - ACCU-CHEK AVIVA & ACCU-CHEK PERFORMA

Roche Diabetes Care has received complaints from one hospital in the United States alleging unexpected results (such as positively biased, or falsely too high, results) when using test strip vials which have opened while still in a sealed carton. The Roche investigation showed that, in very rare circumstances, it is possible that a vial can open in a sealed carton while in transit. This could happen to Accu-Chek Aviva / Accu-Chek Performa test strips, when they are shipped at elevated temperature ( ≥45°C or 113°F) AND when the carton is dropped or handled roughly during the transit and distribution process. It is only when these two conditions occur in combination that the failure mode has been observed

MHRA drug alert link: N/A  

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

If you have any affected product, please dispose of the test strips immediately.

Roche Diabetes Care will provide test strip replacements to users who have purchased vials that were open within the sealed carton.

To obtain replacement from Roche Diabetes Care, please call Roche Diabetes Care Customer Careline at UK: 0800 701 000* or Ireland: 1 800 709 600*

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