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Ticker Update

Updates

SUB-TYPE: COMPANY-LED RECALL

COMPANY-LED DRUG ALERT - RESPREEZA 1,000 MG POWDER AND SOLVENT FOR SOLUTION FOR INFUSION

CSL Behring UK Ltd is recalling the below batches of Respreeza 1,000 mg powder and solvent for solution for infusion (EU/1/15/1006/001) due to a manufacturing deviation that occurred during the filling process. There is a risk of potential microbial contamination due to the failure of the HEPA filters at the manufacturing site and the batches are being recalled as a precautionary measure. This product is only supplied to Pharmacies and/or Hospitals Pharmacies and not to wholesale, via our 3PL partner Alloga UK Ltd

MHRA drug alert link: https://www.gov.uk/drug-device-alerts/company-led-medicines-recall-respreeza-1000-mg-powder-and-solvent-for-solution-for-infusions-eu-slash-1-slash-15-slash-1006-slash-001?utm_medium=email&utm_campaign=govuk-notifications&utm_source=ea5d64be-6beb-4a4b-b8a9-a24edc5aeea8&utm_content=immediately              

Pip code

Product description

Supplier

Batch Numbers

Alliance do not stock

Respreeza 1,000 Mg Powder And Solvent For Solution For Infusion

CSL Behring UK Ltd

P100043501

P100237408

 

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: Jo Heaton (Head of Medical Affairs UK & Ireland, Commercial Operations United Kingdom) CSL Behring UK Ltd by emailing: Jo.Heaton@cslbehring.com

 

Company Contact for stock enquiries

For stock information enquiries, please contact: Karien Pietersen (Head of Quality) CSL Behring UK Ltd by emailing: Karien.pietersen@cslbehring.com

SUB-TYPE: CLASS 2 RECALL

CLASS 2 RECALL - Sodiofolin 50mg/ml Solution for Injection 100mg/2ml

Further to Drug Alert EL (20)A/52 issued on 11 November 2020, medac Pharma LLP is recalling further batches of products following inspection of vials showing hairline damage to the shoulder of the vials. So far, the company has not received any reports of damage for marketed products. However, as this defect may impact on the sterility of the product, the below batches are being recalled as a precautionary measure

MHRA Drug Link: https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-medac-gmbh-t-slash-a-medac-pharma-llp-sodiofolin-50mg-slash-ml-solution-for-injection-100mg-slash-2ml-pl-11587-slash-0005-el-20-a-slash-61?utm_source=84015acc-7689-472c-92fe-db322a8d4537&utm_medium=email&utm_campaign=govuk-notifications&utm_content=immediate

PIP Code

Product Description

Supplier

Affected Batch

Alliance do not stock

Sodiofolin 50mg/ml Solution for Injection 100mg/2ml

Medac Pharma LLP

L180633D

L180633L

L180633P

M190771B

 

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

 

For more information or medical information queries, please contact info@medacpharma.co.uk or telephone 01786 458086.

 

SUB-TYPE: COMPANY-LED RECALL

COMPANY-LED DRUG ALERT - INSTANYL 100MCG SINGLE DOSE

Takeda UK Limited is recalling the below batch of Instanyl 100mcg nasal spray solution (EU/1/09/531/015) due to the observation of cracked vials during inspection of the bulk vials and release testing of the finished products. So far, the company has not received any reports of damage for the marketed products. However, due to the low potential for breaking or cracking of the glass vial, which is contained within the plastic actuator casing and a potential risk of microbial contamination, the above batch is being recalled as a precautionary measure

MHRA drug alert link: https://www.gov.uk/drug-device-alerts/company-led-medicines-recall-instanyl-100mcg-nasal-spray-solution-eu-slash-1-slash-09-slash-531-slash-015?utm_medium=email&utm_campaign=govuk-notifications&utm_source=a6ea9305-5a64-4dd6-ae86-912f9bbbe915&utm_content=immediately         

Pip code

Product description

Supplier

Batch Numbers

3678380

INSTANYL 100MCG SINGLE DOSE

Takeda UK Limited

447055

 

Alliance have not supplied this product and therefore we are not accepting stock returns.

 

Company Contact for medical information enquiries

For medical information enquiries, please contact: Takeda UK Limited by emailing medinfoemea@takeda.com

 

Company Contact for stock enquiries

Remaining stock of these batches should be quarantined and returned to Takeda for replacement stock where available.

 

For stock information enquiries, please contact: Alloga UK by emailing allogaUK.credit.claims@alloga.co.uk

SUB-TYPE: COMPANY-LED RECALL

18.12.2020

Company-Led drug alert Sodium Chloride 0.9% Solution For Injection

Title:  Company-Led drug alert Sodium Chloride 0.9% Solution For Injection
Class type: Company-Led drug alert

Copy: Fresenius Kabi Ltd is recalling the below batch of Sodium chloride 0.9% Solution for injection (PL 08828/0178) which has a polish labelled ampoule within some of the cartons. As this does not impact the full batch, as a precautionary measure Fresenius Kabi are recalling all packs from this batch number. The outer carton is correct and includes the correct patient information leaflet in the English language. The ampoules are the correct composition and specifications as the UK licensed material, however during manufacture the incorrect ampoule label was used. The affected batch is being recalled and all stock will be replaced by corrected stock from Fresenius Kabi Limited.

The affected products' details are as follows:

PIP Code

Product Description

Supplier

Affected Batch

Alliance Do Not Stock

Sodium Chloride 0.9% Solution For Injection

Fresenius Kabi Ltd

20PEF024

Alliance do not stock this product we are not accepting stock returns.

For stock information enquiries, please contact: Fresenius Kabi Ltd customer services centre Email: Customer.Services-UK@Fresenius-Kabi.com

Recipients of this Drug Alert should bring it to the attention of relevant contacts.

SUB-TYPE: FIELD SAFETY NOTICE

17.12.2020

Field Safety Notice - Voluntary Recall Unisex Patterned Sock C1 Med

L&R Medical Uk Ltd (Pway)is recalling the above batches of products as a Field Safety Notice - Voluntary Recall

 

The affected products' details are as follows:

 

PIP Code

Product Description

Supplier

Affected Batch

3570009

UNISEX PATTERNED SOCK C1 MED

L&R MEDICAL UK LTD (PWAY)

203203

 

This is a FSN voluntary recall and Alliance will be accepting stock returns.



For further information, please contact L&R Medical on 08450 606707

 

Recipients of this Drug Alert should bring it to the attention of relevant contacts.

SUB-TYPE: CLASS 2 RECALL

CLASS 2 RECALL - ZERBAXA 1G/0.5G POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

Merck Sharp & Dohme Limited is recalling the below batches due to the presence of Ralstonia pickettii in recent batches that were manufactured. The below batches are recalled as a precautionary measure whilst investigations into the microbiological quality of the distributed products are underway

MHRA drug alert link: https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-merck-sharp-and-dohme-limited-zerbaxa-1g-slash-0-dot-5g-powder-for-concentrate-for-solution-for-infusion-el-20-a-slash-60?utm_source=22cd61e8-ab02-4646-bc21-a8c64c009886&utm_medium=email&utm_campaign=govuk-notifications&utm_content=immediate     

Pip code

Product description

Supplier

Batch Numbers

ALLIANCE DO NOT STOCK

ZERBAXA 1G/0.5G POWDER FOR CONCENTRATE FOR SOLUTION FOR

INFUSION

MERCK SHARP & DOHME LIMITED

S036625

S038424

S041245

T001191

T001192

T031915

 

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

 

For stock control enquiries please contact customerservice.msduk@msd.com

 

Phone number: 01992 452094

 

For more information or medical information at medicalinformationuk@msd.com

 

Phone number: 01992 467272

SUB-TYPE: CLASS 4 CAUTION IN USE

16.12.2020

Class 4 Drug Alert (Caution in use only) Co-Careldopa 25mg/100mg tablets

 

Fairmed Healthcare GmbH has informed us of a discrepancy on the product packaging for some batches. The discrepancy relates to the incorrect spelling of one of the active pharmaceutical ingredients printed on one side of the packs in error.

 

The affected products' details are as follows:

 

PIP Code

Product Description

Supplier

Affected Batch

7089238

CO-CARELDOPA TAB 25/100MG (100)

FAIRMED HEALTHCARE GMBH

DT1912007A

DT1912006A

DT1910014B

DT1900015A

DRA07037A

DRA07036A

DRA01030A

1068535

CO-CARELDOPA TAB 25/100MG (100)

FAIRMED HEALTHCARE GMBH

 

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



For more information or medical information queries, please contact:

 

Fairmed Healthcare GmbH

Dorotheenstraße 48, 22301

Hamburg, Germany, Quality Assurance Department

or via email on QA Manager: l.rozikova@fair-med.com

 

Recipients of this Drug Alert should bring it to the attention of relevant contacts.

SUB-TYPE: CLASS 4 CAUTION IN USE

16.12.2020

Class 4 Drug Alert (Caution in use only) Perindopril Erbumine 2mg, 4mg & 8mg Tablets

Generics [UK] Limited t/a Mylan have informed us that the Patient Information Leaflet (PIL) within the packs for the products listed above is missing relevant important safety information.

 

The affected products' details are as follows:

 

PIP Code

Product Description

Supplier

Affected Batch

Alliance do not stock

Perindopril Erbumine 2mg Tablets

Generics [UK] Limited t/a Mylan

3109619

3116084

Alliance do not stock

Perindopril Erbumine 4mg Tablets

Generics [UK] Limited t/a Mylan

3112399

8104332

Alliance do not stock

Perindopril Erbumine 8mg Tablets

Generics [UK] Limited t/a Mylan

8104319

 

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

 

For more information or medical information queries, please contact: Generics [UK] Limited t/a Mylan Medical Information Direct Line +44 (0)1707 853 000 select option 1, Customer Care direct line +44 (0)1707 853 000 select option 2 or via Medical Information e-mail info@mylan.co.uk

 

Recipients of this Drug Alert should bring it to the attention of relevant contacts.

SUB-TYPE: CLASS 3 RECALL

CLASS 2 RECALL - SIMVADOR 10, 20 & 40mg TABLETS

Lupin Healthcare (UK) Limited has informed us that the affected batches below (also distributed by Discovery Pharmaceuticals/Dexcel Pharma Limited) have been packaged with a version of patient information leaflet (PIL) that does not include the most up to date safety information..”   

MHRA drug alert link: https://www.gov.uk/drug-device-alerts/class-3-medicines-recall-lupin-healthcare-uk-limited-simvador-10mg-20mg-and-40mg-tablets-el-20-a-57?utm_source=22bc7d72-98a3-44b2-b529-22cffbe3f477&utm_medium=email&utm_campaign=govuk-notifications&utm_content=immediate    

Pip code

Product description

Supplier

Batch Number

2941441

SIMVADOR TABS 10MG

LUPIN HEALTHCARE

G902211

2941458

SIMVADOR TABS 20MG

LUPIN HEALTHCARE


G902283

 

2941466

SIMVADOR TABS 40MG

LUPIN HEALTHCARE

G803251

G803252

G803253

G803254

G803255

G902245

G902242

G902243

G902241

 

For stock control enquiries please contact +44 (0) 1565 751 378 Option 2 or information@lupin.com

 

For more information or medical information enquiries please contact +44 (0) 1565 751 378 Option 1 or

Pharmacovigilance Department at EU-PV@lupin.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

 

This recall will remain open for 3 months from the date issued unless an alternative date is agreed by instigator. The closure of this will be 04/03/2021. Please note after this date customer returns may still be accepted but customers may not be credited.

SUB-TYPE: CLASS 2 RECALL

CLASS 2 RECALL - BETAHISTINE DIHYDROCHLORIDE 8MG & 16MG TABLETS

Kent Pharmaceuticals Ltd has informed us that the affected batches above are contaminated with theophylline due to a cross-contamination issue identified with an excipient that was used in the manufacture of the finished product. Therefore, a decision has been taken to recall the affected batches

MHRA drug alert link: https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-kent-pharmaceuticals-ltd-betahistine-dihydrochloride-8mg-and-16mg-tablets-el-20-a-55?utm_source=40c23525-b2da-4a2b-9a24-fc70e06dce17&utm_medium=email&utm_campaign=govuk-notifications&utm_content=immediate

Pip code

Product description

Supplier

Batch Numbers

Alliance do not stock

Betahistine dihydrochloride 8mg Tablets

Kent Pharmaceuticals Ltd

EC10619

EC10719

EC10819

Alliance do not stock

Betahistine dihydrochloride 16mg Tablets

Kent Pharmaceuticals Ltd

GY11119

GY11219

GY11319

 

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

 

For stock control enquiries please contact customer.service@kent-athlone.com

 

For more information or medical information medical@kent-athlone.com