SUB-TYPE: FIELD SAFETY NOTICE
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
Pip code | Product description | Supplier | Batch Numbers |
3981214 | ACCU-CHECK PERFORMA T/STRIPS | ROCHE | ALL STOCK |
3171253 | ACCU-CHEK AVIVA BLD T/STRIP | ROCHE | ALL STOCK |
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.
SUB-TYPE: COMPANY-LED RECALL
Potentially contaminated with an impurity
MHRA drug alert link: N/A
Pip code | Product description | Livery | Batch Numbers |
8449241 | PI APROVEL TAB 150MG | DONCASTER PHAMA | FT050/3218 |
For further information please contact:
Sales and customer service
Rebecca Platts: Rebecca.platts@doncatser-pharm.com
01302552961
Quality Assurance
Richard Gore: Richard.Gore@doncaster-pharm.com
01302554805 or out of hours 07736297267
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: FIELD SAFETY NOTICE
Smith & Nephew Medical Ltd. has initiated a field action to voluntarily remove multiple lots of the JELONET 5x5CM. There is a potential for a sterile barrier breach and paraffin leakage due to manufacturing error
MHRA drug alert link: N/A
Pip code | Product description | Supplier | Batch numbers |
2170439 | JELONET 5X5CMSQ BP | SMITH & NEPHEW H/CARE MED | 202018 202019 202020 202021 202022 202036 |
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
Brown & Burk UK Limited would like to notify you of an error regarding specific batches of Amoxicillin 500 mg/ 5 ml Powder for oral suspension, sold and distributed in the UK. The product information incorrectly states the quantity of the excipient sodium benzoate. The actual quantity of sodium benzoate is 3.75mg/5ml. On the PIL it is incorrectly reported as 7.5mg/5ml and in the SmPC it is 15mg/5ml (1.5mg/ml)
Pip code | Product description | Supplier | Batch numbers |
8943789 | AMOXICILLIN SF SOLN 500MG/5ML | Brown & Burk UK Limited | ASDBV0001 ASDBV0002 ASDBV0003 |
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.
For more information, medical information queries please contact:
Email: pv@bbukltd.com
For stock enquiries please contact:
Email: customercare@bbukltd.com
Tel: 0203 384 7188.
SUB-TYPE: FIELD SAFETY NOTICE
Bausch + Lomb is conducting a recall of certain lots of Biotrue®, ReNu® and ReNu® MultiPlus Boston® and Boston® Simplus Multi-action, Sensitive Eyes™ and EasySept® contact lens solution since we cannot confirm the compliance of the supplier’s sterilization process used for some components of these products.
MHRA drug alert link: N/A
Pip code | Product description | Supplier | Batch numbers |
2229870 | BOSTON ADVANCE CONDITIONING | BAUSCH & LOMB UK | MD1843 MD2246 |
3021060 | BAUSCH&LOMB SALINE SENSITIVE EYES | BAUSCH & LOMB UK | ME2386 |
3244613 | RENU MULTI-PURPOSE | BAUSCH & LOMB UK | ME2728 ME3685 ME4641 |
3289220 | RENU MULTI-PURPOSE FLIGHT PACK | BAUSCH & LOMB UK | ME4222 ME4581 MF0344 MF2996 MF3411 |
If you have any questions, please contact Bausch + Lomb Customer Service.
Email: Pharma_CS@bausch.com
Phone: 0845 602 2350
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
Napp Pharmaceuticals Limited would like to notify you of an error regarding specific batches of Sevredol 10 mg Tablets and Sevredol 20 mg Tablets, sold and distributed in the UK. The error identified relates to approved safety-related variations to the PIL that were not implemented, resulting in an older version of artwork being used and packed within finished batches
Pip code | Product description | Supplier | Batch Numbers |
0089771 | SEVREDOL TAB 10MG | NAPP PHARMACEUTICALS LIMITED | 243406 244570 |
0089805 | SEVREDOL TAB 20MG | NAPP PHARMACEUTICALS LIMITED | 244573 |
Alliance healthcare do not stock this product therefore we are not accepting stock returns.
For more information, medical information queries or replacement PIL enquiries, please contact: medicalinformationuk@napp.co.uk
For stock control queries, please contact:supplies.uk@napp.co.uk
If you have any questions, then please contact your local Service Centre Customer Services team.
SUB-TYPE: CLASS 4 CAUTION IN USE
Galderma UK would like to notify you of an error identified by Galderma regarding specific batches of Tetralysal 300mg Hard Capsules, sold and distributed in the UK. The error identified relates to approved safety-related variations to the PIL that were not implemented, resulting in an older version of artwork being used and packed within finished batches. Additional warnings, precautions and side effects have been updated in the latest version of the PIL
Pip code | Product description | Supplier | Batch Numbers |
2361137 | TETRALYSAL 300 CAP | GALDERMA UK | 881 |
3042819 | TETRALYSAL 300 CAP | GALDERMA UK | 853 869 |
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.
For more information, medical information queries or replacement PIL enquiries, please contact: medinfo.uk@galderma.com
For stock control queries, please contact: sales.uk@galderma.com
If you have any questions, then please contact your local Service Centre Customer Services team
SUB-TYPE: CLASS 2 RECALL
Kyowa Kirin Limited is recalling the below batches as a precautionary measure, due to the reports of glass and cellulose fibre contamination, which was identified during stability and reference sample inspection
Pip code | Product description | Supplier | Batch numbers |
8350837 | XOMOLIX 2.5MG/ML SOLUTION FOR INJECTION | KYOWA KIRIN | 1821A 1919 |
Further information
For Stock control enquiries please contact
Karen Murray, Commercial Manager
Telephone: +44 (0) 1896 661665 / Mobile: +44 (0) 7712 001288
Email: karen.murray@kyowakirin.com
For Medical information enquiries please contact
Medical Information Direct Line: + 44 (0)1896 664 000
Email: medinfo@kyowakirin.com
For Quality information please contact
Martin Smith (Responsible Person)
Telephone: Mobile: +44 7904671807
Email: Martin.Smith@kyowakirin.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.
SUB-TYPE: CLASS 2 RECALL
Bristol Laboratories Limited, Brown & Burk UK Ltd and Teva UK Ltd are recalling the below batches of products 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
Bristol Laboratories Limited
Pip code | Product description | Livery | Batch Numbers |
1149657 | Irbesartan 75 mg Film Coated Tablets | Bristol Laboratories Limited | POM0007 POM0008 POM0009 POM0010 |
6359616 | Irbesartan 75 mg Film Coated Tablets | Bristol Laboratories Limited | POM0007 POM0008 POM0009 POM0010 |
1149715 | Irbesartan 150 mg Film Coated Tablets | Bristol Laboratories Limited | PON0005 PON0006 PON0007 PON0008 PON0009 |
6359624 | Irbesartan 150 mg Film Coated Tablets | Bristol Laboratories Limited | PON0005 PON0006 PON0007 PON0008 PON0009 |
1176536 | Irbesartan 150 mg Film Coated Tablets | Bristol Laboratories Limited | PON0005 PON0006 PON0007 PON0008 PON0009 |
1149665 | Irbesartan 300 mg Film Coated Tablets | Bristol Laboratories Limited | POO0005 |
6359608 | Irbesartan 300 mg Film Coated Tablets | Bristol Laboratories Limited | POO0005 |
1176544 | Irbesartan 300 mg Film Coated Tablets | Bristol Laboratories Limited | POO0005 |
Brown and Burk UK Limited
Pip code | Product description | Livery | Batch Numbers |
1149657 | Irbesartan 75 mg Film Coated Tablets | Brown and Burk UK Limited | IAAG017 IAAG018 IAAG019 IAAG022 IAAG023 |
6359616 | Irbesartan 75 mg Film Coated Tablets | Brown and Burk UK Limited | IAAG017 IAAG018 IAAG019 IAAG022 IAAG023 |
1149715 | Irbesartan 150 mg Film Coated Tablets | Brown and Burk UK Limited | IABG033 IABG034 IABG035 IABG037 IABG038 IABG039 IABG051 |
6359624 | Irbesartan 150 mg Film Coated Tablets | Brown and Burk UK Limited | IABG033 IABG034 IABG035 IABG037 IABG038 IABG039 IABG051 |
1176536 | Irbesartan 150 mg Film Coated Tablets | Brown and Burk UK Limited | IABG033 IABG034 IABG035 IABG037 IABG038 IABG039 IABG051 |
1149665 | Irbesartan 300 mg Film Coated Tablets | Brown and Burk UK Limited | IACG027 IACG028 IACG032 IACG035 IACG036 IACG037 |
6359608 | Irbesartan 300 mg Film Coated Tablets | Brown and Burk UK Limited | IACG027 IACG028 IACG032 IACG035 IACG036 IACG037 |
1176544 | Irbesartan 300 mg Film Coated Tablets | Brown and Burk UK Limited | IACG027 IACG028 IACG032 IACG035 IACG036 IACG037 |
1186840 | Irbesartan/Hydrochlorothiazide 150mg/12.5mg Film Coated Tablets, | Brown and Burk UK Limited | IZAG020 |
8382673 | Irbesartan/Hydrochlorothiazide 150mg/12.5mg Film Coated Tablets, | Brown and Burk UK Limited | IZAG020 |
1186857 | Irbesartan/Hydrochlorothiazide 300mg/12.5mg Film Coated Tablets, | Brown and Burk UK Limited | IZCG010 |
8382681 | Irbesartan/Hydrochlorothiazide 300mg/12.5mg Film Coated Tablets, | Brown and Burk UK Limited | IZCG010 |
1186832 | Irbesartan/Hydrochlorothiazide 300mg/25mg Film Coated Tablets | Brown and Burk UK Limited | IZBG008 |
8382665 | Irbesartan/Hydrochlorothiazide 300mg/25mg Film Coated Tablets | Brown and Burk UK Limited | IZBG008 |
Teva UK Limited
Pip code | Product description | Livery | Batch Numbers |
1178870 | Losartan potassium 50mg Film Coated Tablets | Teva UK Ltd | 108885 |
8023574 | Losartan potassium 50mg Film Coated Tablets | Teva UK Ltd | 108885 |
1207570 | Losartan potassium 50mg Film Coated Tablets | Teva UK Ltd | 108885 |
1153626 | Losartan potassium 50mg Film Coated Tablets | Teva UK Ltd | 108885 |
1150150 | Losartan potassium 50mg Film Coated Tablets | Teva UK Ltd | 108885 |
1205707 | Losartan potassium 50mg Film Coated Tablets | Teva UK Ltd | 108885 |
8113706 | Losartan potassium 50mg Film Coated Tablets | Teva UK Ltd | 108885 |
1178888 | Losartan potassium 100mg Film Coated Tablets | Teva UK Ltd | 106077 |
8023566 | Losartan potassium 100mg Film Coated Tablets | Teva UK Ltd | 106077 |
1207588 | Losartan potassium 100mg Film Coated Tablets | Teva UK Ltd | 106077 |
1153618 | Losartan potassium 100mg Film Coated Tablets | Teva UK Ltd | 106077 |
1150168 | Losartan potassium 100mg Film Coated Tablets | Teva UK Ltd | 106077 |
Further Information
Bristol Laboratories Limited
For more information or medical information queries please contact notifications@bristol-labs.co.uk
For supply queries, please contact notifications@bristol-labs.co.uk
Brown & Burk UK Ltd
For more information or medical information queries please contact pv@bbukltd.com
For supply queries, please contact customercare@bbukltd.com or 0203 384 7188
Teva UK Limited
For more information or medical information queries please contact Teva Medical Information at
medinfo@tevauk.com or 0207 540 7117
For supply queries, please contact Teva Customer Solutions at customer.services@tevauk.com or
0800 590502
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 1 RECALL
Zentiva Pharma UK Limited is recalling the below batch of Co-Codamol 30/500 Effervescent Tablets as a precautionary measure due to an issue with the homogeneity of the batch. This issue means that there is the potential for some tablets to have too little active ingredients (codeine phosphate and paracetamol) in them and some tablets to contain too much active ingredients. The current investigation has highlighted that tablets have been identified where the content of both codeine and paracetamol is less than the label claim.
Pip code | Product description | Livery | Batch Numbers |
1132463 | CO-CODAMOL EFF TAB 30/500MG | ZENTIVA PHARMA UK | 1K10121 |
1096700 | CO-CODAMOL EFF TAB 30/500MG | ZENTIVA PHARMA UK | 1K10121 |
We would like to draw your attention to the following quote from the MHRA: MHRA Chief Quality and Access officer, Dr Samantha Atkinson, said:
Patient safety is always our priority. It is vitally important that people urgently check their packs of Zentiva Pharma UK Ltd Co-codamol 30/500 Effervescent Tablets and if the batch number corresponds to 1K10121, they should stop using them and return them to their pharmacy for a replacement immediately.
For more information or medical information queries please contact 0800 0902408 or email UKMedInfo@zentiva.com.
For supply queries, please contact 0844 8793188 or email 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.