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Ticker Update

Updates

SUB-TYPE: CLASS 4 CAUTION IN USE

Class 4 Drug (Caution in use) - SmofKabiven Central emulsion for Infusion

Fresenius Kabi Limited have identified an error on the infusion bag packaged into the above batches. In the energy content section printed onto the bag the amount of carbohydrates (glucose anhydrous) has been incorrectly declared as 150g, the actual amount is 125g.

 

MHRA drug alert link:

https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-smofkabiven-central-emulsion-for-infusion-fresenius-kabi-ltd-el-21-a-slash-37?utm_medium=email&utm_campaign=govuk-notifications&utm_source=5a6a839e-bd5e-40f6-92dd-6c73adf4498f&utm_content=immediately   

 

Pip code

Product description

Livery

Batch Numbers

Alliance do not stock

SMOFKABIVEN CENTRAL EMULSION FOR INFUSION

FRESENIUS KABI LIMITED

10PK7682

10PL9065

10QA9950

10QC4068

10QG7923

10QI9859

10QL2802

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

 

Further Information

For more information or medical information queries please contact:

Medical.Information-UK@fresenius-kabi.com

 

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

SUB-TYPE: COMPANY-LED RECALL

Company Led Recall - VITAMIN D3 DROPS

A quality issue has recently been identified in relation to the dispensing method used in the Vitamin D3 Drops for infants

MHRA drug alert link: N/A   

Pip code

Product description

Supplier

Batch numbers

8033185

VITAMIN D3 DROPS

PRO HEALTH SOLUTIONS LIMITED

LOT 2101001

 

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 - MYDRILATE EY/D 0.5%

Intrapharm Laboratories Ltd are recalling the below batch of Mydrilate 0.5 % Eye Drops 5ml as a precautionary measure due to out of specification results for related substances obtained during stability testing

MHRA drug alert link: https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-intrapharm-laboratories-ltd-mydrilate-0-dot-5-percent-eye-drops-5ml-el-21-a-slash-35?utm_medium=email&utm_campaign=govuk-notifications&utm_source=ae9c5b07-b1e0-4f64-bd26-24f1907b748f&utm_content=immediately

Pip code

Product description

Supplier

Batch numbers

0186783

MYDRILATE EY/D 0.5%

INTRAPHARM LABORATORIES

YE096

 

Further Information

 

For more information or medical information queries, please contact: Redline Pharmacovigilance, email: medinfo@intrapharmlabs.com, Contact number: 0330 1359 437

 

For stock control queries, please contact: Lauren Johnson, Commercial Affairs Manager, Intrapharm Laboratories Ltd, email: Lauren.Johnson@riemser.com; Landline: 01628 771800.

 

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 - VARIOUS MARKETING AUTHORISATION HOLDERS AND PARALLEL DISTRIBUTOR COMPANIES

Important update:

 

Further to the recall below, the MHRA have sent an updated version with the below changes.

 

Change made:

Batch ET042/2156 has been added to BR Lewis Pharmaceuticals, 150mg Aprovel section (this batch number has been added in the table below).

 

Updated link:

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-34?utm_medium=email&utm_campaign=govuk-notifications&utm_source=51215d28-2f33-4366-a0f9-0eb7cd46f26b&utm_content=immediately

 


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-34?utm_medium=email&utm_campaign=govuk-notifications&utm_source=1bddc3b6-a77c-46a3-9a16-7732942ac3dc&utm_content=immediately   

 

Aventis Pharma Limited T/A Sanofi

 

Pip code

Product description

Supplier

Batch Numbers

ALLIANCE DO NOT STOCK

CO-APROVEL FC 150MG/12.5MG

SANOFI

9R1PC

ALLIANCE DO NOT STOCK

CO-APROVEL FC 300MG/12.5MG

SANOFI

9R1P9

Parallel Distributors

Chemilines Ltd

 

Pip code

Product description

Livery

Batch Numbers

8449241

PI APROVEL TAB 150MG

CHEMILINES

FT022/001

FT022/002

FT022/003

7108988

PI APROVEL TAB 300MG

CHEMILINES

FT020/001

7028699

PI CO-APROVEL FC 150MG/12.5MG

CHEMILINES

FT020/001

7028681

PI CO-APROVEL FC 300MG/12.5MG

CHEMILINES

FT037/001

Drugsrus Ltd (Repackaged by P.I.E Pharma Ltd)

Pip code

Product description

Livery

Batch Numbers

ALLIANCE DO NOT STOCK

PI CO-APROVEL FC 150MG/12.5MG

DRUGSRUS LTD (REPACKAGED BY P.I.E PHARMA LTD)

K/066

 

 

Lexon (UK) Ltd

Pip code

Product description

Livery

Batch Numbers

ALLIANCE DO NOT STOCK

PI APROVEL TAB 300MG

LEXON (UK) LTD

FT027

 

BR Lewis Pharmaceuticals Ltd (Repackaged by Doncaster Pharmaceuticals Group Ltd)

Pip code

Product description

Livery

Batch Numbers

8449241

PI APROVEL TAB 150MG

BR LEWIS PHARMACEUTICALS LTD (REPACKAGED BY DONCASTER PHARMACEUTICALS GROUP LTD)

ET042/2156

FT022/2994

FT022/3112

FT040/3218

FT052/3228

7108988

PI APROVEL TAB 300MG

BR LEWIS PHARMACEUTICALS LTD (REPACKAGED BY DONCASTER PHARMACEUTICALS GROUP LTD)

FT027/3124

FT027/3079

7028699

PI CO-APROVEL FC 150MG/12.5MG

BR LEWIS PHARMACEUTICALS LTD (REPACKAGED BY DONCASTER PHARMACEUTICALS GROUP LTD)

9R1PC

 

Gowrie Laxmico Ltd T/A B&S Healthcare

 

Pip code

Product description

Livery

Batch Numbers

ALLIANCE DO NOT STOCK

PI APROVEL TAB 150MG

GOWRIE LAXMICO LTD T/A B&S HEALTHCARE

06R1441

06T0238

07R0792

11R0446

05T0766

05T0767

10R0284

ALLIANCE DO NOT STOCK

PI CO-APROVEL FC 150MG/12.5MG

GOWRIE LAXMICO LTD T/A B&S HEALTHCARE

06R1475

08R0102

10R0532

08R0074

ALLIANCE DO NOT STOCK

PI CO-APROVEL 300MG/25MG TABLETS

GOWRIE LAXMICO LTD T/A B&S HEALTHCARE

05R1210

 

 

Quadrant Pharmaceuticals Ltd (Repackaged by Maxearn Ltd)

Pip code

Product description

Livery

Batch Numbers

ALLIANCE DO NOT STOCK

PI APROVEL TAB 150MG

QUADRANT PHARMACEUTICALS LTD (REPACKAGED BY MAXEARN LTD)

7790R

1390T

1655T

1392T

1652T

9494T

9619T

1905U

4908R

ALLIANCE DO NOT STOCK

PI APROVEL TAB 300MG

QUADRANT PHARMACEUTICALS LTD (REPACKAGED BY MAXEARN LTD)

9486T

 

OPD Laboratories Ltd

Pip code

Product description

Livery

Batch Numbers

ALLIANCE DO NOT STOCK

PI APROVEL TAB 150MG

OPD LABORATORIES LTD

FT051/1

FT051/2

FT051/3

FT052/1

ALLIANCE DO NOT STOCK

PI CO-APROVEL FC 150MG/12.5MG

OPD LABORATORIES LTD

FT020/1

 

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 2525.

 

Chemilines

For more information or medical information queries, please contact Ashutosh Pradhan at Ashutosh.pradhan@chemilines.com.

 

For supply queries, please contact Nisha Brar at Nisha.brar@chemilines.com.

 

BR Lewis Pharmaceuticals Ltd / Doncaster Pharmaceuticals Group Ltd

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

 

Drugsrus Ltd

For more information or medical information / supply queries, please contact Drugsrus Limited at recall@drugsrus.co.uk or 0208 423 3800.

 

Lexon (UK) Ltd

For more information or medical information queries, please contact Yogesh Patel at yogesh.patel@lexonuk.com or 07515 765513.

 

For supply queries, please contact Heather Jordan at heather.jordan@lexonuk.com.

 

Gowrie Laxmico Ltd T/A B&S Healthcare

For more information or medical information queries, please contact medinfo@bnsheathcare.com or 0800 049 9401 ext 941.

 

For supply queries, please contact customerservice@bnshealthcare.com.

 

Quadrant Pharmaceuticals Ltd

For all enquiries please contact Radoslaw Bandomir at radoslaw.bandomir@maxearn.co.uk.

 

OPD Laboratories Ltd

For more information or medical information queries, please contact Sasi Vimalaranjithan / Hemang Patel at 01923 332 796 or sasi@sigmaplc.com / hemang@sigmaplc.com.

 

For supply queries, please contact Vasanth Samson / Krina Shah at qa@sigmaplc.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.

 

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

SUB-TYPE: CLASS 4 CAUTION IN USE

Class 4 Drug Caution in use - MOMETASONE FUROATE 50 MICROGRAM / DOSE NASAL SPRAY, SUSPENSION

PilsCo Ltd. have identified a error relating to the wording on the outer carton label. The label affixed on the bottle states: ‘use within 2 weeks of first use’, instead of the correct label statement which should be: ‘use within 2 months of first use

 

MHRA drug alert link: https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-mometasone-furoate-50-microgram-slash-dose-nasal-spray-suspension-pilsco-ltd-el-21-a-slash-33?utm_medium=email&utm_campaign=govuk-notifications&utm_source=e049222e-87bd-466b-af5c-870967570da8&utm_content=immediately    

Pip code

Product description

Livery

Batch Numbers

1197151

MOMETASONE N/SPRAY 50MCG

PILSCO LTD

KT1782

KT1781

KV4290

KV4303

KR4651

KV4301

KV4299

KV4302

KY6352

KY6322

1188333

MOMETASONE N/SPRAY 50MCG

PILSCO LTD

KT1782

KT1781

KV4290

KV4303

KR4651

KV4301

KV4299

KV4302

KY6352

KY6322

1203967

MOMETASONE N/SPRAY 50MCG

PILSCO LTD

KT1782

KT1781

KV4290

KV4303

KR4651

KV4301

KV4299

KV4302

KY6352

KY6322

 

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

 

Further Information

 

For more information, medical information queries or stock control queries, please contact: Nigel Kelly Nigel@ethigen.co.uk 013555 98155

 

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

SUB-TYPE: CLASS 3 RECALL

CLASS 3 RECALL - METHADONE TAB 5MG (PHYSEPTONE 5MG TABLETS)

Martindale Pharma is recalling the below batch of Methadone 5mg tablets as a precautionary measure due to the discolouration of the PVdC film in a small number of blister pockets

MHRA drug alert link: https://www.gov.uk/drug-device-alerts/class-3-medicines-recall-martindale-pharma-an-ethypharm-group-company-methadone-5mg-tablets-slash-physeptone-5mg-tablets-el-21-a-slash-31?utm_medium=email&utm_campaign=govuk-notifications&utm_source=c480fd76-d520-4a64-9570-f410b38c7b35&utm_content=immediately   

Pip code

Product description

Supplier

Batch numbers

8032484

METHADONE TAB 5MG (PHYSEPTONE 5MG TABLETS)

MARTINDALE PHARMA

128319

 

Further Information

 

For more information please contact:

 

Customer Services for stock control enquiries: Licensed@ethypharm.com

 

or for Medical Information enquiries: medinfo@martindalepharma.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, 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 3 RECALL

CLASS 3 RECALL - METHADONE TAB 5MG (PHYSEPTONE 5MG TABLETS)

Martindale Pharma is recalling the below batch of Methadone 5mg tablets as a precautionary measure due to the discolouration of the PVdC film in a small number of blister pockets

MHRA drug alert link: https://www.gov.uk/drug-device-alerts/class-3-medicines-recall-martindale-pharma-an-ethypharm-group-company-methadone-5mg-tablets-slash-physeptone-5mg-tablets-el-21-a-slash-31?utm_medium=email&utm_campaign=govuk-notifications&utm_source=c480fd76-d520-4a64-9570-f410b38c7b35&utm_content=immediately   

Pip code

Product description

Supplier

Batch numbers

8032484

METHADONE TAB 5MG (PHYSEPTONE 5MG TABLETS)

MARTINDALE PHARMA

128319

This product is a Schedule 2 Controlled Drug, so please use the Returns Portal for any recalled stock you may need to return to ensure there is authorization to return. When you are completing the portal if you are returning a split pack Please include exact number of tablets you are returning. If you are unable to use the Returns Portal please call Customer Services for assistance.

Further Information

 

For more information please contact:

 

Customer Services for stock control enquiries: Licensed@ethypharm.com

 

or for Medical Information enquiries: medinfo@martindalepharma.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, 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 - IKERVIS EYE DROPS 0.1% & VERKAZIA 0.1% EYE DROPS UD

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

MHRA drug alert link: https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-santen-oy-trading-as-santen-uk-limited-and-parallel-distributor-ikervis-1-mg-slash-ml-eye-drops-emulsion-and-verkazia-1-mg-slash-ml-eye-drops-emulsion-el-21-a-slash-30?utm_medium=email&utm_campaign=govuk-notifications&utm_source=ed7060ba-57ef-42eb-89b1-ac5b77c8be8a&utm_content=immediately  

 

Pip code

Product Description

Supplier

Batch Numbers

3986395

IKERVIS EYE DROPS 0.1%

SANTEN UK LIMITED

8K38Q

4L41F

8L28C

4087276

VERKAZIA 0.1% EYE DROPS UD

SANTEN UK LIMITED

1L14P

4L40H

6L04J

N/A

PI IKERVIS EYE DROPS 0.1%

ORIFARM A/S

6L03F

 

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

 

 

Further Information

 

Santen UK Limited

For more information, please contact +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

 

Orifarm A/S

For all enquiries please contact:

 

Paul Tobin (Responsible Person) on 07583577513 or email at paul.tobin@orifarm.com

 

Steven Cross (UK Parallel Import Sales Manager) on 07498975920 or email at steven.cross@orifarm.com

 

 

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

SUB-TYPE: CLASS 4 CAUTION IN USE

Class 4 Drug Caution in use - SLENYTO 1 MG AND 5MG PROLONGED RELEASE TABLETS

Flynn Pharma Ltd, distributors of Slenyto 1 mg and 5mg prolonged release tablets would like to notify you 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-slenyto-1-mg-and-5mg-prolonged-release-tablets-distributed-by-flynn-pharma-ltd-el-21-a-slash-29?utm_medium=email&utm_campaign=govuk-notifications&utm_source=918a7eae-bd86-4833-899a-5114d92b0980&utm_content=immediately      

 

Pip code

Product description

Supplier

Batch Numbers

4102091

SLENYTO 1MG PROLONGED RELEASE TAB

FLYNN PHARMA LTD

1049309A

1049310

1049311

1049312

1051815

80419B

90287

10175A

10186

4102083

SLENYTO 5MG PROLONGED RELEASE TAB

FLYNN PHARMA LTD

00130

00409C

10058

 

 

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

 

Further Information

 

For more information, medical information queries or replacement PIL enquiries, please contact:

 

Flynn Pharma Ltd Medical Information Department on 01438 727822, email – medinfo@flynnpharma.com.

 

For stock control queries, please contact: Flynn Pharma Ltd on 01438 727822

 

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

SUB-TYPE: COMPANY-LED RECALL

COMPANY-LED DRUG ALERT - DOTAREM SOLUTION FOR INJECTION (10ML VIAL)

Guerbet Laboratories Ltd is recalling the below batches of Dotarem 10ml vials, due to the potential risk of a sterility break, based on the evidence of external leaks of the solution (dry product on the external surface of the vials)

MHRA drug alert link: https://www.gov.uk/drug-device-alerts/company-led-medicines-recall-dotarem-solution-for-injection-10ml-vial-pl-12308-slash-0016?utm_medium=email&utm_campaign=govuk-notifications&utm_source=6e2cf2cc-77cb-4717-a214-e7df6d710c9c&utm_content=immediately        

Pip code

Product description

Supplier

Batch numbers

ALLIANCE DO NOT STOCK

DOTAREM SOLUTION FOR INJECTION (10ML VIAL)

GUERBET LABORATORIES LTD

21GD006B04

21GD006C01

 

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 James Bradley (GDP RP):

 

james.bradley@guerbet.com

 

Company Contact for stock enquiries

 

For stock information enquiries,

 

UK Customer Services

 

uk.sales@guerbet.com

 

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