Czech Republic
France
Germany
Norway
Netherlands
Spain
Turkey
United KingdomUpdates
SUB-TYPE: CLASS 3 RECALL
Class 3 recall-Trimbow Inhaler 87MCG/5MCG/9MCG
Chiesi Ltd has informed the MHRA about a potential issue with the batches listed in this notification. As a precautionary measure, Chiesi Ltd is recalling the above batches at the pharmacy and wholesale level. This is due to intermittent high results for the uniformity of delivered dose of formoterol fumarate observed during stability testing
MHRA Drug alert link:
Pip code | Product description | Supplier | Batch Numbers |
4055067 | TRIMBOW INH 87MCG/5MCG/9MCG | CHIESI LIMITED (ALLT) | 1165031 1150215 |
Further information
For medical information enquiries please contact medinfo.uk@chiesi.com or telephone 0161 488 5555.
For stock control enquiries please contact customerservices.uk@chiesi.com or telephone 0161 488 5521.
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: Gemcitabine Solution for Infusion 2000mg/200ml
Sun Pharma UK Ltd has informed the MHRA of a labelling issue with one batch of Gemcitabine 2000mg/200ml infusion.
MHRA drug alert date: 7th September 2023
Pip code | Product description | Supplier | Batch Numbers |
1211143 | GEMCITABINE INF BAG 2000MG | Sun Pharma | HAE0427A |
Further Information
For medical information enquiries, please contact:
Email: medinfoeurope@sunpharma.com
Tel: 0208 848 5052
For stock information enquiries, please contact: Sun Pharma UK Customer Services
Email: Cserv.uk@sunpharma.com
Tel: 0208 848 5050
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 Caution in use- Duraphat 5000ppm toothpaste
Colgate-Palmolive (U.K.) Limited has informed the MHRA that the Patient Information Leaflet (PIL), carton and tube of the batches of Duraphat 5000ppm Fluoride Toothpaste (51g) listed above are missing information relating to the presence of allergens in the product.
MHRA drug alert date: 7th September 2023
Pip code | Product | Supplier | Affected Batches |
3207776 | DURAPHAT 5000 SINGLE T'PST | COLGATE PALMOLIVE (RMT) LTD. (DHL) | SEE ABOVE LINK
|
This is a caution in use only we are not accepting stock returns
Further Information
For medical information enquiries or stock control enquiries please contact Colgate-Palmolive (UK) Limited on 00800 321 321 32 or https://www.colgatepalmolive.co.uk/contact-us
SUB-TYPE: CLASS 3 RECALL
Class 3 recall-Evorel Sequi patches
Theramex has informed the MHRA that some cartons of Evorel Sequi contain the incorrect combination of patches. An error at the packaging site means that a limited number of packs have the incorrect combination of Evorel 50 and Evorel Conti patches
Pip code | Product description | Supplier | Batch Numbers |
2421659 | EVOREL SEQUI PATCH | THERAMEX UK | 6029403 |
Further Information
For medical information enquiries please contact the Theramex Medical Information Department on 033 3009 6795 or via email: medinfo.uk@theramex.com
For pharmacy stock control enquiries please contact Alliance Customer Services Team on 020 3962 5555.
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 Caution in use- Tostran gel 2%
Kyowa Kirin Limited has notified MHRA that the priming instructions in the current PIL for Tostran 2% gel require updating.
Following a manufacturing change to the Tostran 2% gel dosage pump/dispenser system, the manufacturer has observed that the priming instruction requires changing. Data from the end of shelf life in-use testing has shown that the number of actuations required to prime the device to achieve correct dosing increases over time. This means that more pumps to prime the device being using it for the first time are now required. If these instructions are not followed then a less accurate first dose may be delivered. The Patient Information Leaflet and Summary Product Information will be updated to include these the new priming instructions, subject to approval by MHRA.
MHRA drug alert date: 31st August 2023
MHRA drug alert link:https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-kyowa-kirin-limited-tostran-testosterone-2-percent-gel-el-23-a-slash-33
Product | Supplier | Affected Batches | |
3263266 | TOSTRAN GEL 2% | KYOWA KIRIN LTD | 2649810 2649850 2649860 2649820 2661080 2661090 2650030
|
This is a caution in use only we are not accepting stock returns
Further Information
For medical information enquiries please contact at medinfo@kyowakirin.com.
Tel: +44 (0)1896 664 000.
For stock control enquiries please contact customerqueries-uk@kyowakirin.com.
Tel: +44 (0) 7712 001288.
SUB-TYPE: CLASS 2 RECALL
Class 2 recall-Epistatus 2.5mg Oromucosal Solution (pre-filled oral syringes)
Veriton Pharma Limited is recalling a specific batch of Epistatus (midazolam) 2.5mg Oromucosal Solution (pre-filled oral syringes) due to confirmed out of specification results related to the product appearance. Following a market complaint, the batch listed in this notification was investigated and it was confirmed that there is potential for some products to appear cloudy and/or contain crystalline particles. The Summary of Product Characteristics (SmPC) states that the product should be a ‘clear colourless to pale yellow solution.’ Additionally, there is specific information that states ‘do not use if the solution is not clear (e.g. cloudy or white particles are present).’
MHRA drug alert date: 30 August 2023
PIP CODE | DESCRIPTION | SUPPLIER | AFFECTED BATCHES |
5400759 | EPISTATUS 2.5MG ORAL PFS GB | Veriton Pharma Ltd | 230327A2 |
Further Information
For medical information enquiries please contact Veriton Pharma Limited by emailing to centralmedicalinformation@veritonpharma.com or via the direct line: +44 (0)1932 690325. For stock control enquiries please contact Veriton Pharma Limited by emailing to orders@veritonpharma.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.
SUB-TYPE:
AmerisourceBergen becomes Cencora, in alignment with the company’s growing global footprint and central role in pharmaceutical access and care
New name of company reflects unified global presence and collective goal of creating healthier futures by accelerating positive outcomes for customers and their patients
Company announces more than $5 million commitment to global corporate philanthropic efforts
CONSHOHOCKEN, Pa. (August 30, 2023) – Cencora, Inc. (NYSE: COR) today announced the completion of its name and stock ticker change from AmerisourceBergen Corporation (NYSE: ABC), marking the latest stage of the company’s evolution as a leader in global pharmaceutical services. Cencora will begin trading under the new ticker symbol “COR” on the New York Stock Exchange at the open of the market trading today, August 30, 2023.
Under the new name Cencora, the company unifies its 46,000 employees – across several global business segments – under one identity, propelled by a bold vision and purpose-driven approach to creating healthier futures.
The new name underscores Cencora’s experience and vision when it comes to connecting manufacturers, providers, pharmacies and patients, and ensuring the consistent, reliable flow of treatments to those who need them at a time of growing complexity.
"Today is a significant and exciting milestone for Cencora. Our new name is a reminder of our customers, their patients, and our team members who are at the center of everything we do,” said Steven H. Collis, Chairman, President & Chief Executive Officer of Cencora. “It represents the healthier futures we strive for serving as a trusted industry partner that prioritizes innovation, advocates for patient access, and advances strategic partnerships across the global pharmaceutical value chain.”
As a global healthcare company, Cencora will continue to invest in and focus on its core pharmaceutical distribution business, while also growing its platform of pharma and biopharma services to support pharmaceutical innovation and access across the globe.
Aligned with the company’s purpose, and to commemorate this seminal moment in the organization’s history, Cencora also announced a $5 million donation to the Cencora Impact Foundation, formerly known as the AmerisourceBergen Foundation, an independent not-for-profit charitable giving organization. The donation will be used to launch the Cencora Healthier Futures Grant Program, which aims to identify opportunities to support those on the front lines of healthcare in underserved populations who are driving innovation in global health. Targeted donations from the Cencora Healthier Futures Grant Program, operated by Cencora Impact Foundation, will go toward nonprofits and charities around the world that are advancing access to care and directly impacting communities in need.
The inaugural donation out of the Cencora Healthier Futures Grant Program will be a $500,000 grant made to the UNICEF Health Fund, which focuses on ensuring every child has the ability to survive and thrive by providing strong primary healthcare systems, training healthcare professionals, and working closely with national governments to ensure programs are replicable at scale. These system-wide responses aim to reduce the number of maternal and newborn deaths, provide children with immunizations, reduce malnutrition, address adolescent mental health, and combat the rise of non-communicable diseases.
“We are grateful for support from the Cencora Impact Foundation to help UNICEF deliver large-scale, sustainable results in ensuring the health of the world’s most vulnerable children,” said V. Renée Cutting, Chief Philanthropy Officer, UNICEF USA.
Cencora Ventures, formerly known as AB Health Ventures, the company’s dedicated corporate venture fund, has also committed to donating 10% of future realized profits to support the efforts of the Cencora Impact Foundation and its continued work to improve healthcare access globally.
For more information about the rebrand and updated design and branding elements, visit: www.cencora.com
About Cencora
Cencora is a leading global pharmaceutical solutions organization centered on improving the lives of people and animals around the world. We partner with pharmaceutical innovators across the value chain to facilitate and optimize market access to therapies. Care providers depend on us for the secure, reliable delivery of pharmaceuticals, healthcare products, and solutions. Our 46,000+ worldwide team members contribute to positive health outcomes through the power of our purpose: We are united in our responsibility to create healthier futures. Cencora is ranked #11 on the Fortune 500 and #24 on the Global Fortune 500 with more than $200 billion in annual revenue. Learn more at www.cencora.com
SUB-TYPE: CLASS 4 CAUTION IN USE
Class 4 Caution in use- Loceryl nail lacquer
Galderma (U.K.) Limited has informed the MHRA that a pallet of Loceryl 5% w/v Medicated Nail Lacquer from a batch licensed only for distribution in Ireland has been inadvertently placed into the UK supply chain due to a warehousing error at their UK pre-wholesaler. Although Loceryl is a registered medicine in both Ireland and the UK, there are differences between these products in the product labelling and Patient Information Leaflet (PIL) packaged with the medicine.
MHRA drug alert date: 29th August 2023
Pip code | Product | Supplier | Affected Batches |
0256313 | LOCERYL NAIL LACQUER | GALDERMA (U.K.) | 2212421*
|
This is a caution in use only we are not accepting stock returns
Further Information
If you require more information, have further medical information enquiries (including replacement PIL enquiries) then please e-mail: medinfo.uk@galderma.com. For stock control queries, please contact: sales.uk@galderma.com
SUB-TYPE:
Supporting the NHS – a Q&A with couple who both work for the NHS
Last month we celebrated 75 years of the NHS. This prompted us to take look closer at our amazing National Health Service. We caught up with a Jim (a GP) and Marie (an intensive care nurse) who have both worked for the NHS for over thirty years.
What has your experience been working with the NHS?
Jim: I am very proud to have worked for the NHS for 36 years and it is a privilege to work for such an amazing organisation. The NHS has evolved and changed over the years to accommodate the changing demographics and needs of its population. It has been incredibly hard work but enormously rewarding.
Marie: I’ve worked for the NHS for 40 years and my experience has generally been very good. Whilst the work has been difficult both mentally and physically, particularly in the last few years, it is incredibly rewarding. Working alongside amazing colleagues helps you through the tougher moments.
Coming out of the pandemic, how has your work evolved?
Jim: We have embraced new technology, supported our patients and each other and tried to develop strategies to cope with a staggering increase in demand.
Marie: More of the day-to-day has moved online, it is much busier, there are less staff and higher expectations. It must be said that the pandemic has drastically changed the way that we work, and the way that the public see us. That said, I feel immensely proud to have been able to work in intensive care during the pandemic. It was extremely difficult, but the work that every member of staff did during that time was incredible.
Do you have a message for the NHS as it celebrates its 75th year?
Jim: Keep working hard to care for your patients, embrace change, support your colleagues and staff. Know that you are doing a great job and are much appreciated.
Marie: The NHS is a wonderful institution that I’ve been proud to work for my whole career. My message to all NHS workers is to keep doing what you’re doing – the hardest moments will be worth it; you are making a difference every day.
SUB-TYPE: CLASS 2 RECALL
Class 2 Recall - Sodiofolin 50 mg/ml solution for injection/infusion
Medac GmbH (t/a medac Pharma LLP) is recalling the products and respective batches in this notification due to particles detected during long-term stability tests.
Further to EL(23)/A26 medac GmbH (t/a medac Pharma LLP) have identified further batches that are impacted. medac GmbH (t/a medac Pharma LLP) is recalling the products and respective batches in this notification due to particles detected during long-term stability tests. As stated in the Summary of Product Characteristics (SmPC): ‘Only clear solutions without visible particles should be used.’. These batches are being recalled as a precautionary measure and the root cause analysis investigation remains ongoing.
MHRA drug alert date: 21 August 2023
|
|
|
| ||||
|
|
|
|
Further Information
For all medical enquiries, please contact medical information at medac Pharma LLP by email to info@medacpharma.co.uk or by telephone 01786 458086.