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SUB-TYPE: CLASS 2 RECALL

Class 2 Recall on Valsartan

Teva UK Limited and Mylan are recalling some Valsartan containing products including certain batches supplied by Teva UK Limited and all unexpired batches supplied by Mylan.

Please visit the: MHRA website for more details on this drug alert.

The affected products' details are as follows:

PIP CodeProduct DescriptionLiveryAffected Batches
8466179VALSARTAN TAB 40MGTEVA UK LIMITED100350
100938
101776
1166909VALSARTAN TAB 40MG TEVTEVA UK LIMITED100350
100938
101776
1167535VALSARTAN TAB 40MG GUKTEVA UK LIMITED100350
100938
101776
1161546VALSARTAN TAB 40MG ACTTEVA UK LIMITED100350
100938
101776
8466245VALSARTAN TAB 320MGTEVA UK LIMITED100433
101777
1166917VALSARTAN TAB 320MG TEVTEVA UK LIMITED100433
101777
1173152VALSARTAN TAB 320MG ACTTEVA UK LIMITED100433
101777
1166958VALSARTAN HCTZ TAB80/12.5MG TEVTEVA UK LIMITED6P601163
6P606333
0001584
0002626
0002627
0003214
0004744
8466203VALSARTAN HCTZ TAB 80MG/12.5MGTEVA UK LIMITED6P601163
6P606333
0001584
0002626
0002627
0003214
0004744
1161520VALSARTAN HCT TAB 80/12.5MG ACTTEVA UK LIMITED6P601163
6P606333
0001584
0002626
0002627
0003214
0004744
8466161VALSARTAN HCTZ TAB 160MG/25MGTEVA UK LIMITED6P601084
6P606270
0000350
0000352
0001997
0002338
0003615
1166941VALSARTAN HCT TAB 160/25MG TEVTEVA UK LIMITED6P601084
6P606270
0000350
0000352
0001997
0002338
0003615
1162353VALSARTAN HCT TAB 160/25MG ACTTEVA UK LIMITED6P601084
6P606270
0000350
0000352
0001997
0002338
0003615
8466195VALSARTAN HCTZ TAB 160MG/12.5MGTEVA UK LIMITED6P607166
0000426
0001520
0001521
0002298
0003663
0004670
1166966VALSARTAN HCT TAB 160/12.5MG TEVTEVA UK LIMITED6P607166
0000426
0001520
0001521
0002298
0003663
0004670
1161538VALSARTAN HCT TAB 160/12.5MG ACTTEVA UK LIMITED6P607166
0000426
0001520
0001521
0002298
0003663
0004670
1167626VALSARTAN CAPSULES 80MG ACTMYLANALL STOCK
1166883VALSARTAN CAP 80MG TEVMYLANALL STOCK
8466229VALSARTAN CAP 80MGMYLANALL STOCK
1166214VALSARTAN CAP 80 MG GUKMYLANALL STOCK
1166875VALSARTAN CAP 40MG TEVMYLANALL STOCK
1167618VALSARTAN CAP 40MG ACTMYLANALL STOCK
8466237VALSARTAN CAP 40MGMYLANALL STOCK
1166206VALSARTAN CAP 40 MG GUKMYLANALL STOCK
1166891VALSARTAN CAP 160MG TEVMYLANALL STOCK
8466211VALSARTAN CAP 160MGMYLANALL STOCK
1166222VALSARTAN CAP 160 MG GUKMYLANALL STOCK
1167634VALSARTAN CAPSULES 160MG ACTMYLANALL STOCK

Teva UK Limited

For stock control: general.enquiries@tevauk.com

For medical information enquiries: medinfo@tevauk.com

 

Mylan

For stock control: mguk_customer.services@mylan.co.uk, 01707 853100

For medical information enquiries: info@mylan.co.uk, 01707 853 000, Option 1

Any stock returned after the 30th April 2019 will not receive credit.

 

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 Recall on Zoledronic acid 5mg solution for infusion

Ranbaxy (UK) Ltd a Sun Pharmaceutical Company, has informed us that some packs from the above batch contain a Patient Information Leaflet (PIL) for Temozolomide 180mg Capsules..

Please visit the: MHRA website for more details on this drug alert.

The affected products' details are as follows:

PIP CodeProduct DescriptionLiveryAffected Batch

1186964Zoledronic acid 5mg solution for infusionRanbaxy (UK) LtdJKT1576A

For any enquiries, please contact Ranbaxy / Sun Pharmaceuticals customer services team: Tel: 020 8848 5050; email: cserv.uk@sunpharma.com.
 

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

 

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

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

SUB-TYPE: CLASS 2 RECALL

Class 2 Recall on Ranitidine 150mg & 300mg Tabs Accord Healthcare

Accord Healthcare are recalling all unexpired stock of the above products from pharmacies and wholesalers as a precautionary measure due to possible contamination with an impurity Nnitrosodimethylamine (NDMA) which has genotoxic and carcinogenic potential.

 

Please visit the: MHRA website for more details on this drug alert.

 

The affected products' details are as follows:

PIP CodeProduct DescriptionSupplierAffected Batch
7056195RANITIDINE TAB 150MGAccord HealthcareALL STOCK
1069087RANITIDINE TAB 150MGAccord HealthcareALL STOCK
7056203RANITIDINE TAB 300MGAccord HealthcareALL STOCK
1069046RANITIDINE TAB 300MGAccord HealthcareALL STOCK
1179191RANITIDINE TABS 150MGAccord HealthcareALL STOCK

For stock control enquiries please contact Accords Customer Service team on 0800 373573

For medical information enquiries please contact Accords Pharmacovigilance Department on 01271 385257 or medinfo@accord-healthcare.com

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

 

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 2 RECALL

Class 2 Recall on Paracetamol 500mg (1000s) M&A Pharma

M & A Pharmachem is recalling the above batches as a precautionary measure, because a small number of pots from some batches have been found to contain discoloured tablets due to fungal contamination. The fungus has been identified as Penicillium citrinum. It is unlikely that any affected tablets will have got to patient level as the discolouration is noticeable on opening affected packs.

 

Please visit the: MHRA website for more details on this drug alert.

 

The affected products' details are as follows:

PIP CodeProduct DescriptionSupplierAffected Batch
7018393PARACETAMOL TAB BP 500MGM&A PHARMACHEMALL STOCK

For enquiries relating to stock returns please contact Pauline Caddick, Responsible Person: pcaddick@mapharmachem.co.uk

For Medical information enquiries, please contact Cristina Parau, Pharmacovigilance Manager: email cparau@mapharmachem.co.uk

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

 

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 3 RECALL

Class 3 Drug Alert (Action Within 5 Days) Taxotere Concentrate 80mg per 4ml

Sanofi are recalling the listed batches of Taxotere (Docetaxel) Concentrate due to a production fault potentially leading to an increase in the concentration of Docetaxel in the solution.

Please visit the: MHRA website for more details on this drug alert.

The affected products' details are as follows:

PIP CodeProduct DescriptionSupplierAffected Batch
3556727Taxotere (Docetaxel) Concentrate for Solution for Infusion, 80mg per 4mlSanofi UK5F219A

Company contact for all enquiries: Sanofi Medical Information Department on Tel: 0845 3727101 or Email: UK-Medicalinformation@sanofi.com

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

 

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 3 RECALL

Class 3 Drug Alert (Action Within 5 Days) Algivon Alg Strl Drsg 10cmsq X 5

Advancis Medical Ltd are recalling the below batch due to the potential packaging integrity.

Please visit the GOV.UK drug alert link: N/A

The affected products' details are as follows:

PIP CodeProduct DescriptionSupplierAffected Batch
3193703Algivon Alg Strl Drsg 10cmsq X 5Advancis MedicalWO013976

Action:

1. Contact our sales team (inese.haqure@brightwake.cauk) to request a Return Goods Number (RGN) so that we can reconcile and replace all potentially affected product.

2. Please return the affected product listed above to receive replacement.

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

 

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 Alert (Caution in use only) Convulex 500mg Capusles

G.L. Pharma GmbH would like to inform Healthcare professionals that they are aware that there is an error on the carton for batches 5E048A and 5H155A in relation to the strength. Inadvertently, the information "Each capsule contains 150 mg valproic acid." was printed on one side of the cartons instead of the correct "Each capsule contains 500 mg valproic acid." All other information, especially the main headings on the package ("Convulex® capsules 500 mg"), however is correct on the carton. G.L. Pharma GmbH confirms that capsules are 500mg strength. The correct strength is also given on the primary blister pack and the patient information leaflet. G.L. Pharma GmbH have informed the MHRA and the MHRA have approved the continued distribution of batches 5E048A and 5H155A until replacement stock is available.

The affected products' details are as follows:

PIP CodeProduct DescriptionSupplierAffected Batches
0560656Convulex 500mg CapuslesPfizer Ltd5E048A
5H155A

SUB-TYPE: COMPANY-LED RECALL

Company-Led Dotarem Solution for Injection 15ml

GUERBERT have issued a precautionary recall because a glass particle has been identified in one syringe from this batch..

Please visit the: MHRA website for more details on this drug alert.

The affected products' details are as follows:

PIP CodeProduct DescriptionSupplierAffected Batch
Alliance Healthcare Do Not StockDotarem Solution for Injection 15mlGuerbert9263

For further stock enquiries please contact Guerbet Sales Department on 0121 7338542.
 

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

 

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: COMPANY-LED RECALL

Company-Led Drug Alert Fludarabine 25mg/ml, 1 x 2ml

Sandoz is recalling this batch because particulate matter, believed to be intrinsic to the active pharmaceutical ingredient, was identified in samples.

Please visit the: MHRA website for more details on this drug alert.

The affected products' details are as follows:

PIP CodeProduct DescriptionSupplierAffected Batch
Alliance Do Not StockFludarabine 25mg/ml, 1 x 2mlSandoz LtdER 4824

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

Please contact Sandoz Customer Services for all enquiries relating to the issue on Telephone: 01276 698607
 

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

 

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 Alert (Caution in use only) Genotropin Goquick 5.3mg and Genotropin Goquick 12mg

Pfizer Limited has notified us of a manufacturing defect in the dosing mechanism of some Genotropin GoQuick pens which are used to administer somatropin.

Please visit the: MHRA website for more details on this drug alert.

The affected products' details are as follows:

PIP CodeProduct DescriptionSupplierAffected Batch
3568979Genotropin Goquick 12mgPfizer LtdAll unexpired batches
3568961Genotropin Goquick 5.3mgPfizer LtdAll unexpired batches

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

Please contact Pfizer's endocrine helpline, tel 0800 521249; email endocrinecare@pfizer.com

Alternatively contact Pfizer Medical Information, tel 01304 616161
 

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

 

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.